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"Beijing Medical Device Review and Verification Consultation 300 Questions" (Volume 1)
 

  Part I Active Products

  1. How should software components be described in product technical requirements?
  A: If the medical device contains software components, the software name, release number, full version number should be described in Part I (Product model/specification and division description), and if the software components are control software, the software operating environment (including hardware configuration, software environment, and network conditions) should also be described.。The full clinical functional outline of the software should be specified in the second part (Performance requirements)。
  2. For PACS products, how to determine the detection unit in the same registration unit ?
  A: The testing unit of PACS (that is, the registered inspection representative product within the same registration unit) is in principle consistent with the registration unit,However, if there are multiple runtimes (architectures) or multiple releases,Each incompatible operating environment (architecture) or each release that does not cover each other should be used as a unit of detection。For PACS, since the server and client may support operation in multiple environments, the inspection unit should be determined according to the multiple operating environments declared by the product。For the server side, incompatible operating systems supported by the product (such as Windows, Mac OS, Linux, etc.) should be used as a separate detection unit。For the client, according to the operation mode can be divided into native application (C/S) and Web browser (B/S)。For native applications,Supported incompatible software environments (such as Windows),Mac OS,Linux, etc.) should be used separately as a detection unit,For Web browsers,Supported incompatible browsers (IE, Chrome, Firefox, etc.) should be used as a separate detection unit。
  3, the software function is simple, there is no complex image or data processing function, whether the core algorithm can be written is not applicable?
  A: No。Core algorithms are algorithms that are necessary to implement the core functions of the software (functions necessary for the software to accomplish its intended purpose in the environment in which it is intended to be used), including but not limited to imaging algorithms, post-processing algorithms, and artificial intelligence algorithms。Whether it is a core algorithm has nothing to do with the simple function algorithm。
  4. In the product technical requirements of active products, what are the requirements of "Product model/specification and its division description"?
  A: Product technical requirements should be clear product model, specifications。For products with multiple models and specifications in the same registration unit, the division description of different models and specifications should be clearly defined (it is recommended to use the form of illustration and/or table), and the content with more descriptive text can be listed in the appendix。For independent software or products containing software components, the name, model specifications, release version, and naming rules for the full version of the software should also be clear, and the operating environment (including hardware configuration, software environment and network conditions) of the control software components should also be clear.。
  5. Whether network security documents can be incorporated into software description documents?
  A: A separate network security document should be submitted in accordance with the Guiding Principles for Technical Review of Medical Device Network Security Registration。
  6, whether all active medical devices do not refer to the GB/T 14710 standard in the product technical requirements?
  A: In accordance with the Guiding Principles for the Preparation of Technical Requirements for Medical Device Products, the environmental requirements for medical appliances will not be written into the technical requirements for medical device products。However, if the mandatory standard applicable to the declared product requires the implementation of the GB/T 14710 standard, it shall be tested in accordance with the GB/T 14710 standard and the relevant requirements of the mandatory standard。If the declared product is used in a special environment (such as high temperature, high humidity or low temperature), supporting information should be provided in the stability study that the product can be used in the corresponding environment。
  7. How to determine the shelf life of active medical devices?
  A: The shelf life of medical devices refers to the period to ensure that the final product of medical devices plays the expected function normally, and the product design and development stage needs to complete the product shelf life study。You can list the use status of the product,Complete analysis of clinical use,Directly carry out the aging test of the product;The product (system) can also be broken down into different subsystems/components for evaluation, Decomposition relationships should be analyzed in detail,On this basis, the service life of the product is determined through different decomposition methods (such as dividing the product into key components and non-critical components, etc.)。
  8, how to provide medical electrical environment related verification data?
  A: Environmental requirements for medical appliances are to evaluate products in various working environments and
  The adaptability of simulated storage and transportation environment is generally considered to be a stability evaluation item。Different climatic and mechanical environmental conditions can be developed for testing, or the situation of the whole machine can be evaluated through the test of key components, and the comparison of similar products on the market can also be judged。
  9. How to determine the validity period of software products?
  A: The service life of independent software can be determined by commercial factors。The service life of the software component is the same as that of the medical device to which it belongs, and there is no need to reflect it separately。The service life requirements of specialized independent software as a software component are the same as those of independent software, which are reflected in the service life research data of the medical device。
  10. The product technical requirements of medical X-ray diagnostic equipment only describe the computer configuration, and do not specify the computer brand, specifications, models and other information. When the computer configuration changes, whether it is necessary to declare the change of license matters?
  A: When the computer configuration is described in the product technical requirements, such as CPU frequency, storage space, memory space, display resolution, etc., the minimum configuration requirements can be described。When the computer configuration is upgraded, the relevant design changes can be verified through the quality management system control。If it does not involve changes in the technical requirements of the product, the registration of changes in license matters may not be carried out。
  11, medical X-ray diagnostic equipment hardware has not changed, only through the software to adjust the high-voltage generator parameters to make the maximum output power changes, can be exempted from electrical safety and electromagnetic compatibility testing?
  A: If the hardware of the product is not changed, only the software parameters are changed, the performance test should be identified for the changed part, and the overall evaluation of the changed part, if it does not involve the electrical safety standard/electromagnetic compatibility standard requirements, electrical safety and electromagnetic compatibility standard testing can be exempted。
  12. If medical X-ray diagnostic equipment is suitable for pediatric population, how should I submit research data?
  A: Because children or newborns are very sensitive to X-rays, if the applicant claims that the device is suitable for the pediatric population, the measures required to reduce the radiation dose of the child or newborn should be provided。If automatic exposure control is designed and calibrated for pediatric patients;Low radiation dose protocols suitable for infants and young children;Special filtration;Lower than the incident radiation dose of an adult,Exposure limit warning;Display and record patient dose information or dose index and other patient information,Eg. age, Height and weight (manually entered or automatically calculated);It has a filter line grid that can be removed without tools。
  13, medical optical endoscopes, medical laser fiber products need to implement YY 0505 standards?
  A: If the medical optical endoscope, medical laser fiber products do not contain electronic components, only contain optical components, you do not need to implement YY 0505 standard。If it contains electronic components (such as RFID identification devices, etc.), it is necessary to implement the YY 0505 standard。
  14. What is a medical diagnostic X-ray device with pediatric applications?
  A: Medical diagnostic X-ray device with pediatric application means an X-ray imaging device intended for use in a pediatric population or intended for use in a pediatric population including a pediatric population (unless the device is not designed to be used in a smaller pediatric population).。
  15, active products apply for additional model license changes, if it does not involve the new standard, can be exempted from submitting a test report?
  A: First of all, it should be confirmed whether the added model and the original model can be used as the same registration unit, if it can be used as the same registration unit, you can apply for permission to change the added model。If no new standard is involved, it should be determined in accordance with the principle of typical models, if the original model can represent the new model, there is no need to repeat the test。
  16, medium frequency therapy instrument, low frequency therapy instrument active product accessory electrode must have medical device filing certificate?
  A: If the electrode is an purchased product, the product that has obtained the registration certificate or filing certificate of the medical device product should be purchased。If homemade, it should meet the requirements of YY 0868-2011 "Electrodes for nerve and muscle stimulators", and biological evaluation should be carried out in accordance with GB/ T 16886 series standards。Relevant requirements such as stickiness and peel strength should be considered in product technical requirements。
  17, active products consider network security, how should the technical requirements of the product requirements?
  A: The registration applicant shall specify the requirements of data interface and user access control in the product technical requirements performance indicators:
  (1) Data interface: transmission protocol/storage format;
  (2) User access control: user identity authentication methods, user types and permissions。
  18, how to determine the hard tube endoscope (second class) product registration inspection representative products?
  A: The basic principles are as follows:
  (1) The registered inspection representative products shall be products in the same registration unit that can represent the safety and effectiveness of other products in the unit;
  (2) The products with the most complete functions, the most complex structure and the highest risk should be considered;(3) If the main performance of other products is inconsistent with the product under test, the product shall also be registered as a representative product for registration inspection。
  (4) Under normal circumstances,Different maximum values of visual Angle within the same registration unit,The maximum and minimum values are selected for different field angles,Products with different inner and outer diameters and working lengths,Select the one with the smallest diameter and the one with the largest slenderness ratio (length/diameter) for detection,If it contains a working channel,The diameter shall be the outside diameter of the insertion part minus the inside diameter of the working channel。Angular resolution and other optical performance indicators select the most demanding products as a typical product registration inspection。
  19, how to divide the proctoscope (hard tube endoscope products) registration unit?
  A: For proctoscopy, is there an optical system that can be used as the basis for the division of registered units。A product simply contains a guide beam, a peephole, etc,Optical lighting available,No optical system,There are no performance indicators such as field of view Angle and resolution;Another product contains both a light beam,Provide optical lighting,It also contains optical systems,Provides access to observation and imaging (see typical product structure diagram),These two products should be registered as two units。
  20, how to divide the hard tube endoscope (second class) product registration unit?
  A: Under normal circumstances, only the length, diameter, Angle of view, Angle of view, working channel of one or more parameters are different, can be used as the same registration unit, if the difference between the endoscopes beyond the above categories, should be considered should be divided into different registration units。
  (1) Endoscopic active or passive surgical instruments shall be divided into different registration units from endoscopes。
  (2) Endoscopes with different scopes of application should be divided into different registration units, such as laryngoscope, sinus scope, urethral cystoscope, the principle and structure of the basic no major changes, each product as a registration unit。
  (3) Endoscopes and equipment used together (such as cold light sources, camera systems, etc.) should be divided into different registration units。
  (4) Special endoscopes, such as fluoroscopes, endoscopes with PDD, and endoscopes with optical designs different from those described above for typical endoscopes (such as variable focus endoscopes, short depth of field endoscopes, and variable working distance endoscopes), should be divided into different registration units from ordinary endoscopes。
  (5) Endoscopes with different imaging modes should be divided into different registration units。For example, hard optical mirror and hard fiber mirror, hard optical mirror and hard electronic mirror should be divided into different registration units。
  Part II Passive products
  21. Can medical cold packs be registered as Class II medical devices? What is the product classification code?
  A: Medical cold packs with physiotherapy effects (such as pain relief and other effects) are managed as the second type of medical devices, and the classification code is 09-02-03。
  22, how should orthodontic wire products be divided into registration units?
  A: The proposed division of key performance indicators due to different materials
  For different registration units, such as stainless steel orthodontic wire, nickel-titanium alloy orthodontic wire should be different registration units, type I orthodontic wire and type II orthodontic wire should be different registration units。
  23, whether biological research must carry out biocompatibility experiments?
  A: Biocompatibility testing is only one way to conduct biological evaluation。Enterprises can use the available data to conduct biological evaluations and justify exemptions from biological tests。
  24, endoscope with living sampling forceps how to divide the registration unit?
  A: It is recommended that the disposable living sampling forceps and the repeated use of endoscopic living sampling forceps be divided into different registration units, and the sampling forceps for soft endoscopes and the sampling forceps for hard endoscopes should be divided into different registration units。
  25. How to fill in the application form for the first registration of passive products Category II medical device products "Product Overview" when applying for the first registration?
  A: Suggestions: product classification basis, classification code, naming basis, working principle/mechanism of action, structural composition, scope of application and other relevant information。
  26, when applying for the first registration, how to fill in the application form for the first registration of passive products of the second type of medical device products "Product safety and effectiveness evaluation"?
  A: Recommendation description: product performance indicators and determination basis, product testing, product material/processing AIDS use and biological evaluation, product clinical evaluation, product purification production/clean environment production, product sterilization confirmation/microbial control, product validity and verification, product packaging and packaging integrity verification,As well as the overall risk control of the product as described above。
  27, passive second type of medical device declaration when the first registration in the review data how to describe the product packaging?
  A: Attention should be paid to whether packaging information for all product components has been clearly stated,If all components are packaged as a whole or divided into multiple independent packages,The product has several layers of packaging from inside to outside,The material/material standard, quantity and placement of each layer of product packaging,Information identified on each layer of packaging,Instructions to ensure that the integrity of the package is clearly identifiable to the end user。For aseptically supplied/required medical devices with microbiological limits,In addition to the above requirements, Does the supplier information, quality control requirements and packaging material/performance test report of the aseptic barrier system also appear clearly,Whether the packaging test report considers the physical and chemical properties of the packaging, the sterilization adaptability of the packaging, the validity period of the packaging, the biocompatibility evaluation of the packaging and other contents in combination with the characteristics of the product。
  28. How should the chemical and physical properties of passive type II medical devices be described when they are first registered?
  答:应明确指标制定的依据(标准 / 指导原则 / 临床文献等);关注产品指导原则提出的应开展的性能研究; 应从材料、工艺、成品三个层面考虑问题,Fully explain the research work carried out,To confirm that the product in physical properties, chemical properties, performance and other aspects can meet the clinical intended purpose of use。
  29, passive second type of medical device product technical requirements in the technical indicators should be formulated?
  A: There should be a basis for the development of technical indicators (national standard/bank standard/guiding principles, etc.);Format in compliance with regulatory requirements;No national standard/line standard/guiding principle,Should be combined with the clinical use and characteristics of the product,Fully consider material properties, physical properties, chemical properties, performance and so on,The requirements formulated should be no less than, no less than similar products already on the market,There should be scientific and reasonable evidence supporting data for the parts that are not considered compared with similar products。
  30. How to define the management classification of medical wound dressings?
  A: If it contains only chemical components, Chinese medicinal materials (or natural plants) and their extracts, etc., and the ingredients contained only play pharmacological, immunological or metabolic effects, or it cannot be proved that it does not play pharmacological, immunological or metabolic effects, it is not managed by medical devices。Example: Plaster。If the ingredients have pharmacological, immunological or metabolic effects (such as antibacterial effects), but also have the role of medical devices, according to the combination of pharmaceutical products management。Instrumental role of dressing: Used for wound care, it can physically shield wound, absorb wound exudate, and provide a microenvironment for wound healing。Band-aids containing antibacterial and anti-inflammatory drugs, traditional Chinese medicine external application products, etc. shall be registered and managed as drugs, and the ingredients contained shall not play pharmacological, immunological or metabolic effects, and shall be managed as medical devices。
  Class III: intended to prevent tissue or organ adhesion, or to be used as artificial skin on chronic wounds (ulcers, pressure sores, bedsores, deep second or third degree burns), or to be fully or partially absorbed by the body。Class II: not absorbed by the body,Contact the following wound,Such as superficial wounds, suture wounds after surgery, mechanical wounds, small wounds, abrasions, cutting wounds, puncture sites of puncture instruments, burns and scalds of degree I or shallow degree II, infant navel mouth wounds, laser/photon/fruit acid skin replacement/micro-plastic surgery wounds,Or aseptically provided。
  Category I: 14-10-02 Band-Aids.2;14-10-08 Liquid, paste dressing.3。
  31. Whether full-mouth dentures of the same material and process in customized movable dentures can be tested as typical models of local dentures?
  A: No, due to differences in performance indicators (see Guidelines for Custom Denture Registration Review)。
  32. Whether the denture products with 3D printed denture models to be declared for the first time should add specifications and models to the license changes of customized dentures?
  A: Denture products with 3D printed denture models for the first time shall be declared according to a separate registration unit for the first time。
  33. How to classify 3D printed denture products?How to name the product and model?
  A: 3D printed dentures are classified according to the 2017 edition of the "Medical Device Classification Catalogue" customized dentures: 17-oral instruments, 06-oral denture manufacturing materials, 04-customized dentures。The product name should meet the requirements of the Rules for Naming General Names of Medical Devices, and customized dentures can be named as customized fixed dentures or customized movable dentures。The name of the model is generally "main material + process + structure function".。(Note: clear "laser selective melting" process)
  34, in the continuation of the registration of medical devices recommended standards and technical requirements, the specification of the text changes, do not involve changes in the substance can be combined with the continuation of registration?
  Answer: According to the Beijing Medical Device rapid review and Approval Measures, article 7: For medical device registration license changes in the specification of product names, specifications, technical requirements, scope of application, etc. do not involve substantive content changes, can be combined with the continuation of registration。
  35, package products have different grade classification of products, how to register and declare?
  A: Package products if there are different levels of classification of products should be registered according to the highest level of classification (if there are both a class and a class two products, according to the class two medical device registration declaration)。
  36, the registration information in the "chapter directory" refers to a total directory written each chapter directory, or each project to do a separate directory?
  A: Each item is a separate table of contents. The chapter table of contents should include all the headings and subheadings of the chapter and indicate the page numbers of the contents in the table of contents。
  37, whether the central suction and central oxygen supply system can be formulated according to different categories of components respectively?
  A: The validity period can be set separately according to the different categories of parts, but the relevant verification or certification information must be submitted in the registration information。
  38, product registration inspection, whether you can entrust the provincial inspection institute?
  A: When the product is commissioned for registration and inspection, it can be commissioned by qualified medical device inspection institutions in other provinces for inspection。Qualified medical device inspection institutions shall comply with the relevant provisions of Article 75 of the Regulations on the Supervision and Administration of Medical Devices。
  39. Is there a prescribed format for writing registration documents?
  A: On September 30, 2021, the State Medical Products Administration issued the "Announcement on the Publication of Medical device registration Information Requirements and Approval Certification Document Format" (No. 121 of 2021), which includes:
  (1) Medical Device Registration Certificate of the People's Republic of China (Form)
  (2) The People's Republic of China Medical Device Change Registration (Filing) Document (Format)
  (3) State Drug Administration Medical Device Clinical Trial Approval Form (Format)
  (4) Format Requirements for Medical Device Registration and Application Data and Approval Documents
  (5) Medical Device Registration and Application Data Requirements and Instructions
  (6) Information Requirements and Instructions for Medical Device Renewal Registration Application
  (7) Medical Device Change Filing/Change Registration Declaration data Requirements and Instructions
  (8) Medical Device Clinical Trial Approval and Application data Requirements and Instructions
  (9) List of Basic Principles for Medical Device Safety and Performance
  40. How to determine the classification and coding of package products?
  A: Package products in the first registration process, should be reviewed in the material production
  Product description clearly product structure composition and product components and accessories and other information。When determining the management category and classification code of package products, the components that play the greatest role in clinical use and have the highest risk in clinical use of the product should be determined, and this component should be used as the classification code of package products。
  The third part of clinical testing products
  41, in vitro diagnostic reagent manual need to clarify the applicable model brand model?
  答:一般来说,生化分析仪、化学发光免疫分析仪、血糖仪、胶体金免疫层析分析仪等需要明确厂家、型号; 酶标仪等半自动仪器无需明确厂家,只需明确参数(如波长)。
  42. How should the in vitro diagnostic reagent products that do not match calibration and quality control products in the kit be described in the manual?
  A: In the manual should be clear its applicable calibration quality control products, can be described as: this product using ××× calibration products, quality control products for performance verification and clinical evaluation, if the use of other manufacturers calibration products, quality control products, each laboratory should verify their own。
  43. Whether dry powder and liquid dosage forms can be declared as one registration unit?
  A: Under the premise of the same composition, dry powder and liquid reagent can be used as different specifications in the same registration unit, and clinical trials can be carried out either (it is recommended to choose dry powder reagent).。
  44. What should be the statistical data for clinical trials of products with multiple test items (such as allergen combinations)?
  A: Analysis and evaluation should be carried out separately for different projects。
  45. For biochemical reagents, if the two institutions use different instrument brands for clinical trials, is it OK?
  A: In principle, the comparison system of the two institutions should be consistent, and if the instruments used by the two institutions are inconsistent, it is necessary to express reasonable reasons and ensure that the clinical protocols of the two institutions are consistent。
  46, when the second type of in vitro diagnostic reagent products need to submit the main raw material research data and process reaction system research data?
  A: When calibration products and quality control products are registered separately, the main raw material research data and process and reaction system research data should be provided, detailing the research on raw material selection, singleness, uniformity, stability and other aspects, as well as the detailed research data on traceability and assignment。New products in Beijing also need to be submitted。Others are subject to specific circumstances。
  47, in vitro diagnostic reagent product analysis performance evaluation data should provide what basic information?
  A: It should include at least:
  (1) the name of the registrant;
  (2) Performance evaluation methods and requirements;
  (3) The name, batch number and validity period of the reagents used in the personality assessment (including calibration products and quality control products);
  (4) Instrument type and serial number (SN) used;
  (5) Time, place and inspection personnel for performance evaluation;
  (6) Specific data and analysis of performance evaluation。
  48. If the storage conditions of in vitro diagnostic reagents are relatively broad (such as -5~35℃), how should the stability study be designed?
  A: If the storage condition given by the enterprise is a broad range (such as -5~35 ° C), then the stability evaluation should be tested in stages, and it is recommended that the performance evaluation be carried out in the following ranges: -20 to 0 ° C, 2~8 ° C, 10~30 ° C and above 30 ° C。
  49, the validity of the product test report?
  A: No。
  50, for the separately registered biochemical multiple calibrators or quality control products, to change the project (such as from 10 items to 15 items), can change the registration?
  Answer: In principle, no, the materials should be submitted according to the new product registration declaration。Unless it can be proved that there is no change in the composition of the product from the original product。
  51. For the calibration products used in conjunction with biochemical reagents, the situation is changed from a single level to a multi-level (before the change, it is a single high-level calibration product, and then diluted to multiple levels during clinical use;After the change, provide calibrators with different dilution in the kit), can you change the registration?
  A: Yes,The following information should be submitted: (1) Technical requirements before and after the change;(2) Test report;(3) Analysis performance evaluation report;(4) Other information that the enterprise needs to change (such as: labels, instructions);(5) If the form of the calibrator changes (freeze-dried powder becomes liquid), Stability studies of calibrators are also required。
  52, biochemical reagent product kit added calibration products or quality control products (the original kit did not provide matching calibration products or quality control products), can change the registration?
  Answer: Yes, but the traceability should be guaranteed。The following information should be submitted:
  (1) Technical requirements before and after the change;
  (2) Test report;
  (3) Analysis performance evaluation report;
  (4) Other information that the enterprise needs to change (such as: labels, instructions);
  (5) Stability research data of calibration products or quality control products;
  (6) Including the quality system assessment report of the added calibration and quality control products。
  53. What information should be submitted if the sample testing amount is changed?
  A: The following information should be submitted:
  (1) Test data on changes;
  (2) Analysis performance evaluation;
  (3) Clinical evaluation;
  (4) Technical requirements of registered products before and after the change (such as changes);
  (5) Instructions before and after the change。
  54, has obtained the medical device registration certificate of colloidal gold qualitative (naked eye interpretation) test strip products, increase supporting instruments for qualitative interpretation, can change the registration?
  A: Yes, please submit the following information:
  (1) Inspection report with supporting instruments;
  (2) Analyze performance evaluation data;
  (3) Clinical evaluation data。
  55, colloidal gold immunochromatography reagents to increase the applicable model, need to submit what information?
  A: The following information should be submitted:
  (1) It is recommended to match the company's instruments;
  (2) If it is used with another instrument manufacturer, it is necessary to provide a cooperation agreement between the two parties, clarify the rights and responsibilities of the two parties and mutual technical support, and provide the other party's registration certificate and specification and other information to prove that the instrument can be open to use;
  (3) If it is used with multiple instrument manufacturers, in addition to the above article 2 requirements, it should also pay attention to whether the working principle of different applicable instruments is basically the same (including the way of reading the reaction zone of the test strip, etc.), and it should be able to explain the reasonable reasons why the kit can be applied to different instruments from the technical level;
  Perform analytical performance evaluations for all applicable models。
  56, dry powder reagents need to have resolubility stability requirements?
  A: Yes。If there is no resolution stability requirement at the time of registration, the instruction manual should indicate the use immediately after resolution。
  57. If there are quality control products in the reagent components, what needs to be clarified in the appendix of product technical requirements?
  A: If there are quality control products in the reagent components, the raw material source of the quality control products, the preparation method of the quality control products, the assignment method, etc., should be clearly defined in the appendix。
  58. If there are calibrators in the reagent components, what needs to be clarified in the technical requirements appendix?
  A: If there is a calibrator in the reagent component, the raw material source of the calibrator, the preparation method of the calibrator, the method of quantity transfer, the calculation of uncertainty, etc., should be clearly defined in the appendix。
  59, immunochromatographic analyzer used in the family situation, do not need to do clinical trials?
  A: If the products belong to the "List of Medical devices exempt from Clinical evaluation", in principle, there is no need to supplement clinical trial data, but a detailed analysis of household risks should be conducted, and relevant evaluation data should be provided if necessary。
  60. Whether the traceability data of the calibration appendix need to be clear about the uncertainty requirements?
  Answer: Uncertainty requirements:
  (1) If the separately declared calibration is traceable to a national or international standard, the uncertainty calculation formula and the limit requirements for the uncertainty should be provided。The calibration target value and uncertainty value shall be given in the instruction manual or label。
  (2) For calibration products that are not separately declared and are traceable to national or international standards, the uncertainty calculation formula shall be provided, but the limit value of the uncertainty is not mandatory。The calibration target value shall be given in the instruction manual or label。
  The fourth medical device production quality management system
  61, "Medical device registration self-test management Provisions" what are the provisions of self-test ability?
  A: Self-test capabilities are as follows:
  (1) General requirements
  Carrying out self-examination during registration,The applicant for registration shall have the ability of self-examination, And the self-inspection work into the medical device quality management system,Equipped with inspection equipment and facilities suitable for product inspection requirements,With the corresponding quality inspection department or full-time inspection personnel,Strict inspection of process control,Ensure that the inspection results are true, accurate, complete and traceable,And take the main responsibility for the self-inspection report。
  (2) Test capability requirements
  a.Personnel requirement。The applicant for registration shall have inspection personnel and management personnel (including audit and approval personnel) suitable for the inspection activities carried out.。The registration applicant shall be equipped with full-time inspection personnel, and the inspection personnel shall be formally employed personnel, and can only work in the enterprise。The educational background, technical ability and quantity of inspectors shall match the product inspection work。Inspectors should be familiar with the relevant laws and regulations, standards and product technical requirements of medical devices,Master test method principle, test operation skills, work instructions, quality control requirements, laboratory safety and protection knowledge, metrology and data processing knowledge, etc,And shall go through the relevant laws and regulations of medical devices, quality management and relevant professional technology training and assessment。
  Inspectors, examiners, approving personnel, etc. shall be authorized by the registration applicant in accordance with regulations。
  b.Equipment and environmental requirements。The registration applicant shall be equipped with the instruments and equipment and environmental facilities that meet the requirements of the inspection method, establish and keep the files, operating procedures, measurement/calibration certificates, use and maintenance records of the equipment and environmental facilities, and trace the quantity value according to the relevant provisions。Laboratories that carry out special professional tests, such as biological evaluation, electromagnetic compatibility, biosafety, in vitro diagnostic reagents laboratories, etc., shall meet their specific professional requirements for environmental facilities。
  c.Sample management requirements。The registration applicant shall establish and implement the test sample management procedures to ensure that the samples are controlled and maintained accordingly。
  d.Check quality control requirements。The applicant for registration shall carry out all inspection activities using appropriate methods and procedures。Where applicable, this includes the assessment of measurement uncertainty and the use of statistical techniques for data analysis。Registration applicants are encouraged to participate in the relevant testing capability verification/inter-laboratory comparison project organized by the competence verification body to improve the testing capability and level。
  e.Control requirements for records。All quality records and original test records as well as technical records such as relevant certificates/copies of certificates shall be filed and kept for the appropriate period。Records include but are not limited to equipment usage records, original inspection records, procurement and acceptance records of raw and auxiliary materials used for inspection, etc。The retention period of records shall comply with the requirements of relevant regulations。
  (3) Management system requirements
  Where the applicant for registration carries out self-inspection, it shall establish and implement a management system suitable for carrying out self-inspection in accordance with the requirements of relevant inspection work and self-inspection of declared products。
  Self-inspection shall be incorporated into the medical device quality management system。The registration applicant shall formulate the quality management system documents (including quality manuals, procedures, operation instructions, etc.) related to the self-inspection work, the risk management of the inspection work carried out and the documents required by relevant regulations of medical devices, etc., and ensure its effective implementation and control。
  (4) Self-test basis
  The applicant for registration shall inspect the products according to the technical requirements of the products to be registered。The formulation of test methods shall be in accordance with the corresponding performance indicators, and priority shall be given to the use of promulgated standard test methods or recognized test methods。The inspection method shall be verified or confirmed to ensure the repeatability and operability of the inspection。For in vitro diagnostic reagent products, the test method should also clearly state the reference/standard products used, sample preparation method, reagent batches and quantities used, test times, calculation methods, etc。
  (5) Other matters
  a.The registration applicant for commissioned production may entrust the commissioned production enterprise to carry out self-inspection, and the registration applicant shall issue the corresponding self-inspection report。The self-inspection capacity of the entrusted production enterprise shall meet the requirements of these provisions。
  b.The domestic group company or its subsidiaries of the domestic registration applicant have laboratories accredited by the China National Accreditation Service for Conformity Assessment,Or the overseas group company or subsidiary of the overseas registration applicant has a laboratory recognized by the overseas government or the corresponding laboratory qualification certification body recognized by the government,Authorized by the group company,A self-test may be carried out by the corresponding laboratory for the registration applicant,The applicant shall issue the corresponding self-inspection report。
  62, "Medical device registration self-test management Provisions" in the commissioning of the inspection provisions?
  A: The requirements for commissioned inspection are as follows:
  (1) fiduciary conditions
  If the registration applicant submits a self-inspection report, if it does not have the inspection ability of some items in the technical requirements of the product, it can entrust the relevant items to a qualified medical device inspection institution for inspection。Qualified medical device inspection institutions shall comply with the relevant provisions of Article 75 of the Regulations on the Supervision and Administration of Medical Devices。
  (2) Evaluation of the trustee
  The registration applicant shall evaluate the qualification and conformity of the inspection ability of the trustee in the medical device production quality management system documents, and establish a list of qualified trustees, and keep evaluation records and evaluation reports。
  (3) Sample consistency
  The registration applicant shall ensure the consistency between the self-tested samples and the entrusted samples, communicate with the entrusted party in a timely manner, inform the problem, and assist in the inspection work。
  (4) Form a self-test report
  The registration applicant shall summarize the report issued by the trustee and form a complete self-inspection report combined with the inspection items completed by the registration applicant。
  For items involving entrusted inspection, in addition to indicating the entrusted inspection institution in the remarks column, the original entrusted inspection report shall also be attached。
  63, which enterprises need to apply for medical device production license?
  Answer: In the district of Beijing engaged in the production of Class II and Class III medical devices, the production enterprise shall apply for a production license to the Beijing Municipal Drug Administration, and provide evidence of the corresponding production conditions and the registration certificate of the medical devices produced。
  64, what are the documents related to the quality management requirements of medical device production?
  A: Manufacturers shall, in accordance with the requirements of medical device production quality management standards, combined with product characteristics, establish and improve the quality management system suitable for the production of medical devices, and ensure its effective operation。
  (1) The former State Food and Drug Administration "Announcement on the release of Medical device production quality management standards" and "Notice on the implementation of Medical device production quality Management standards";
  (2) The former State Food and Drug Administration "Announcement on the release of Medical device production quality Management Appendix Sterile medical devices", "Announcement on the release of Medical device production quality management Appendix Implantable medical devices", "Announcement on the release of Medical device production quality Management Appendix in vitro diagnostic reagents", "on the release of medical device production qualityNotice on Addendum to Standard Dentures for Management Practices, Notice on Issuing Independent Software Addendum to Quality Management Practices for Medical Devices by the State Drug Administration;
  (3)原国家食品药品监督管理总局《十大电子游艺网站》、《十大电子游艺平台首选》、国家药品监督管理局综合司《十大电子游艺网站》。
  65. What is the processing process of the second and third categories of medical device production licenses?What information needs to be submitted?
  A: You can log on to the official website of Beijing Drug Administration (http://yjj) to handle relevant matters.beijing.gov.cn/) - Government services - Guidelines (municipal matters) - Medical device matters, inquire the second and third categories of medical device production license related matters processing process and information to be submitted。
  66, handling the city's second and third categories of medical device production licensing matters are what?
  A: Since May 1, 2022, the application for the issuance of the Medical Device Production License, the change of license matters, the change of registration matters, the extension, the replacement, the cancellation, and the export sales certificate of medical device products shall follow the corresponding procedures formulated by the Beijing Municipal Drug Administration。
  67, before and after May 1, 2022, handle the licensing matters of the "Medical Device Production Supervision and Management Measures", what matters need to pay attention to?
  A: Before May 1, 2022, our bureau has accepted but not yet approved medical device production license matters, after the implementation of the "Production Measures", to meet the conditions, in accordance with the "production Measures" time limit and issue a medical device production license.。The format of the new production license number is "Beijing Drug Administration machinery production Permit ×××××××× ××××××", where the first four digits of × represent the 4-digit license year, and the fifth to eighth digits of × represent the 4-digit license serial number。The Medical Device Production License within the current validity period shall remain valid。After the implementation of the "Production Measures", the "Medical device production license" needs to be changed, extended, reissued, cancelled, the bureau will be handled in accordance with the relevant provisions of the "production Measures"。Altered or reissued license,The validity period is unchanged;Altered, renewed, reissued license,The license number of the arrangement way by the "Beijing food drug safety machinery production xu x x x x x x x x" changed to "Beijing drug safety machinery production xu x x x x x x x x",The numerical number remains unchanged。Has obtained the "medical device production license" of the production enterprise, after the implementation of the "production measures", the workshop or production line of the enterprise to transform, resulting in changes in production conditions, may affect the safety and effectiveness of medical devices, should be reported to the local municipal food and drug administration branch。If the license matters change, the relevant license change procedures shall be handled in accordance with the Production Measures。
  68. What are the key verification contents of the "Medical Device Registration Quality Management System Verification Guide"?
  A: Including institutions and personnel;Plant, facility and equipment;Document management;Design and development;Purchase;The content of production and quality control shall comply with the provisions of the "Medical Device Manufacturing Quality Management Practice" and its appendix。In addition, it is also necessary to pay attention to the content of sample authenticity verification, involving the development and production of samples, product inspection samples, clinical trial samples, retention samples and other related records that can prove their authenticity。
  69, medical device registration quality management system verification and declaration information includes?What are the requirements??
  A: Since January 1, 2022, the registration applicant shall submit the relevant information about the quality management system related to product development and production when applying for the registration of the second type of medical device products, and the Beijing Municipal Drug Administration will no longer set up a separate medical device registration quality management system verification declaration。Specific application information can be seen in the "Notice of Beijing Municipal Drug Administration on the Release of the second Type of medical devices (including in vitro diagnostic reagents) registration Declaration Matters and data requirements" (Notice (2021) No. 4)。
  70. What is the working time limit for the verification of the medical device registration quality management system?
  A: The working time requirements are as follows:
  The Municipal Device Review Center shall organize and complete the system verification work within 30 working days from the receipt of the system verification notice。For the State Food and Drug Administration audit center to participate in the third type of medical device system verification projects, the municipal device review center shall be carried out system verification 5 working days before the written notification to the State food and drug Administration audit center。
  71, medical device registration quality management system on-site verification precautions include what?
  A: Precautions include:
  (1) The applicant for registration shall accept the on-site verification of the system within the time arranged by the Municipal Device Review Center,Those who cannot accept verification due to the epidemic situation or other objective reasons,The applicant for registration shall, upon receipt of the verification notice,Apply to the municipal device review center,After approval,Postpone the registration check,The delay time is not included in the relevant work time limit;
  (2) The Medical Device Technical Evaluation Center of the State Drug Administration shall participate in the on-site verification of the third type of medical device system when necessary。
  72, medical device production quality management standard on-site verification process, what situation exists in the enterprise, the inspection team can suspend the inspection?
  Answer: In the on-site verification, if it is found that the registration applicant is suspected of violating laws and regulations and other reasons that lead to the system on-site verification cannot be carried out normally, the inspection team shall suspend the inspection, and after the verification is completed, it shall decide to continue the system verification or make a conclusion that the verification has not passed。
  73, medical device production quality management standard on-site verification process, what situation exists in the enterprise, the inspection team can carry out extended inspection?
  A: For part of the production process is completed by other production enterprises, that is, the registration applicant purchases customized parts for production, the inspection team can carry out system extension inspection of parts production enterprises。
  74, medical device registration quality management system verification acceptance, consultation time and place is how to stipulate?
  A: The regulations are as follows:
  (1) The registration applicant may submit the registration application materials to Beijing Municipal Government Service Center: No. 1 Xisanhuan South Road, Fengtai District, Beijing (Southwest corner of Liuliqiao) (1st Floor B Island),Weekdays 09:00-12:00 AM,下午 13:30- 17:00,Consultation phone: 89150290。
  (2) The registration applicant may consult the Beijing Medical Device Evaluation and Inspection Center, address is No. 13 Shuche Hutong, Xinjiekou Street, Xicheng District, Beijing, contact number: 58549949。Consultation hours are Monday and Thursday from 9:00 am to 11:30 am and 13:30 PM to 17:00 PM。(except statutory holidays stipulated by the state)。
  75. What are the requirements and applicable standards for clean environment testing of medical devices?
  A: Requirements and applicable standards for clean environment testing of medical devices:
  (1) The registration applicant and the production enterprise can use the corresponding clean environment testing equipment to carry out daily clean environment testing on their own, and can also entrust qualified testing institutions to carry out clean environment testing。When applying for medical device registration quality management system verification, the clean room environment testing report issued by a qualified testing institution should be submitted, and it should be confirmed whether the testing institution is recognized by CNAS or CMA and has a clean environment inspection scope。
  (2) The clean environment test is based on the "sterile Medical device Production Management Specification" (YY0033-2000) standard。
  (3) Clean environment testing should cover all production and inspection of the clean environment, whether to carry out a clean environment or commissioned inspection institutions to carry out clean environment testing, should ensure that the air cleanliness level indicators meet the requirements of medical devices related industry standards。
  76, registration applicants, production enterprises should have products, production environment and other related testing capabilities?
  A: In the daily production process, sterility testing, ethylene oxide residue testing projects should be completed by the enterprise independently, not commissioned testing;Process water and clean environment monitoring projects shall be independently completed by the enterprise, and testing shall not be commissioned。The registration applicant and the production enterprise shall have the equipment corresponding to the test items。
  77, whether the process water can be purchased?
  A: If purified water is used, it should be prepared by itself;Water for injection (sterilization water for injection) can be purchased if the amount is small。
  78, accept the quality management system before on-site verification should do what preparatory work ?
  A: The basic requirements for preparation are as follows:
  (1) The contact number should be kept open;
  (2) Ensure that the person in charge of the enterprise, management representatives, heads of production, quality, technology, procurement and other relevant departments and staff participate in on-site verification;
  (3) In principle, the site should be in a dynamic production state of the applied product;
  (4) Documents and records for on-site verification shall be prepared in advance。Generally, 2 to 3 sets of controlled quality manuals, procedure documents and related work systems, process regulations, operation instructions, etc. should be prepared for the inspection team;Ensure that all records of system operation are provided at the inspection site, such as R&D, production, procurement, inspection, internal audit, management review, customer feedback, etc.
  (5) The introduction of the basic situation of the enterprise and the product situation should be prepared。Generally, you should make slides and control the time to about 10 minutes。The introduction materials shall include the basic situation of the enterprise, the establishment and operation of the quality management system, the working principle of the verification product, the process flow, and the registration of the product。If it is the on-site verification of the review after rectification, it should focus on the problems raised by the inspection team during the last quality management system verification, the rectification measures taken by the enterprise and the completion of the content。
  79. What are the inspection key points guidelines formulated by the Beijing Municipal Drug Administration?
  A: You can log on to the official website of Beijing Drug Administration (http://yjj) for the guidelines on key inspection points formulated by Beijing Drug Administration.beijing.gov.cn/) query, the path is: Home/Special column/Medical device registration and regulation/inspection key guide, to consult。
  80. For sterile and implantable medical devices, what principles should be followed in setting up laboratories?
  A: Aseptic test rooms, microbial limit rooms and positive control rooms (including people flow and logistics are relatively independent) should be established under 10,000 levels.。
  81, what are the requirements of the production environment of common sterile and implantable medical device products?
  A: The production environment requirements of common sterile and implantable medical device products are as follows:
  (1)一次性使用静脉注射针生产环境应当为 10 万级; 静脉留置导管生产环境应当为万级;角膜接触镜(隐形眼镜)生产环境至少为 30 万级,The production process such as the filling of the corneal contact lens (contact lens) with the nursing solution should be carried out at least in the local 100 level environment under 10,000 level;For products without pyrogen (or endotoxin) and particulate requirements,Such as medical masks, medical latex gloves and other products,Its production environment is at least 300,000。
  (2) The stapler (nail) shall be executed in accordance with the appendix of implantable medical devices;Embolization shall be performed in accordance with the appendix of implantable medical devices;Artificial skin shall be implemented in accordance with the appendix of implantable medical devices;Absorbable materials shall be implemented in accordance with the implantable medical device appendix;Care solution products for contact lenses (contact lenses) and contact lenses (contact lenses) shall be implemented in accordance with the appendix of sterile medical devices。
  (3) Sterile medical devices or single-package factory accessories implanted and inserted into blood vessels and requiring subsequent processing (such as filling and sealing) in local 100-level clean rooms under the 10,000 level,The production area of processing, final cleaning, assembly, initial packaging and sealing of its (non-cleaning) parts shall not be lower than the 10,000 level of cleanliness。Such as: intravascular stent, occluder, pacemaker electrode, artificial blood vessel, intravascular catheter, stent delivery system, etc。
  (4) Sterile medical devices implanted into human tissues, directly or indirectly connected with blood, bone marrow cavities or unnatural cavities, or single-package factory accessories, the processing, unwashed, assembly, initial packaging and sealing of their (non-cleaning) parts and other production areas should not be less than 100,000 level of cleanliness。Such as: pacemaker, percutaneous drainage tube (apparatus) blood separation or filter, disposable sterile syringe, disposable sterile infusion set, disposable sterile blood transfusion set, bone plate bone nail, joint prosthesis, bone cement, etc。
  (5) The processing, unwashed, assembly, initial packaging and sealing of sterile medical devices or single-package factory (non-cleaned) parts that come into contact with the damaged surface and mucous membrane of the human body should be carried out in a clean room of not less than 300,000。Such as: sterile dressings, natural duct catheters, tracheal intubation, sterile preservation devices and other nominal sterile devices。The environment required for the processing, final cleaning, assembly, initial packaging and sealing of sterile implantable medical devices or single packaged (non-cleaned) parts that come into contact with the damaged surface of the human body shall be verified and confirmed。
  (6) For aseptic medical devices (including medical materials) that are required or processed using aseptic operation technology, they should be produced in local 100-level clean rooms (areas) under the 10,000 level。Such as: sodium hyaluronate gel。
  (7) Initial packaging materials that are in direct contact with the use surface of sterile medical devices and are used without cleaning,The setting of the cleanliness level of the production environment shall be determined after verification,It is appropriate to follow the same principle as the cleanliness level of the product production environment,Make the quality of the initial packaging materials meet the requirements of the sterile medical devices,If the initial packaging material does not come into direct contact with the surface used for sterile medical devices, It should be produced in a clean room (area) of not less than 300,000 class。Packaging materials used without cleaning in direct contact with the use surface of sterile implantable medical devices,Measures should be taken,Make the packaging materials meet the corresponding cleanliness and sterility requirements,And verified,If the packaging material does not come into direct contact with the surface used for sterile medical devices,It should be produced in a clean room (area) of not less than 300,000 class。
  82, for non-sterile medical devices containing sterile consumables or accessories, according to which standard to conduct registered quality management system verification?
  A: For non-sterile medical devices containing sterile consumables or accessories, the production of sterile consumables or accessories should also meet the requirements of the Appendix to the Quality Management Practice for Medical Devices Production Sterile Medical Devices。
  83, which in vitro diagnostic reagent products need to be produced in a clean environment?
  A: According to the regulations, the following products and processes should be produced in a clean environment。
  (1) The handling of negative, positive serum, plasmid or blood products shall be carried out in an environment of at least 10,000, with relative negative pressure to adjacent areas, and in compliance with protective regulations。
  (2) Enzyme-linked immunosorbent assay reagents, immunofluorescence reagents, immunoluminescence reagents, polymerase chain reaction (PCR) reagents, gold standard reagents, dry chemical reagents, cell media, calibrators and quality control products, enzymes, antigens, antibodies and other active components of the preparation and packaging of products such as solution, coating, packaging, spot film, drying, cutting, film, and inner packagingEqual process link, It should be at least 100,Class 000 clean environment for operation。The packaging of sterile materials must be in local 100 levels。
  84. What are the requirements for the selection and/or confirmation of the primary packaging materials for sterile medical devices?
  A: The registration applicant and the manufacturing enterprise should comprehensively consider the selection and/or confirmation of the initial packaging materials for medical devices according to the characteristics of the product and the sterilization method,The initial packaging of final sterilized medical devices can be selected and/or confirmed with reference to the requirements of "Packaging of Final sterilized Medical Devices" (GB/ T19633-2009)。If you do not have the relevant testing capacity, you can also entrust the corresponding testing capacity of the unit to carry out the work, such as the State Drug Administration of Beijing Medical device quality supervision and inspection center。National drug supervision and administration of medical devices in Beijing quality supervision and inspection center contact information: garden integrates light industry base of Beijing zhongguancun science park, tongzhou hing street light (101111) telephone number: 7 010-7901468/1388/1399 / fax: 1488/1588 010-57901377
  E-mail:yewu@bimt.org.cn
  85. What are the requirements for the commissioned research and development of in vitro diagnostic reagents?
  A: A formal contract or agreement shall be signed with the principal, which shall specify the content of the research, time, acceptance criteria, etc. The entrusted unit shall have the corresponding ability or qualification, have the environment, equipment and personnel conditions suitable for carrying out the research, and the entrusted unit shall provide the original records of the research。
  86, fill in the "Medical device production license Application Form" what are the precautions ?
  A: Note:
  (1) Note on address filling:
  The address of residence in the Application form for Medical Device production License shall be filled in according to the address of residence in the Business License;The production address should be filled in according to the relevant supporting documents of the production site,It is generally room ×× Floor ××, No. ×× Road ××, ×× District, Beijing,Punctuation between multiple production addresses,”分开。
  (2) Precautions for filling in the production scope:
  a.The production scope shall comply with the requirements of the Medical Device Classification Catalogue。For example, the application for the production of electrocardiogram machines,The production scope filled in according to the 2017 edition of the classification catalog should be filled in the management category, class 1 product category and name,For example: Class II: II-07-03 physiological parameter analysis measuring equipment ×××,The production scope filled in according to the classification catalogue of 2002 edition should be filled in the management category, classification code (secondary directory) and name,For example: Class II: II-6821-4 ECG diagnostic instrument ×××。
  b.If the category code of the category catalog of the product is changed, the product should be filled in the corresponding category catalog and should not be filled in repeatedly. If there is no product in the category catalog, fill in "/" under the corresponding production scope.。
  c.The scope of production should be filled in according to the classification of the products produced, such as the production of the second and third categories of medical devices under the same category, should be listed separately。
  d.Use "; "between class III and Class II rangesSeparate, different product categories are separated by punctuation marks ","。Ⅲ and Ⅱ are independent Roman numerals and cannot be replaced by a combination of three or two English letters "Ⅰ"。
  (3) Which personnel include production management personnel, quality management personnel and professional and technical personnel?
  The production management personnel, quality management personnel and professional and technical personnel in the Application Form for Medical Device Production License mainly include all personnel in the production, quality and technical departments of the enterprise, and the number of production management and quality management personnel should be consistent with the list of employees provided。
  (4) The production area of the Medical device Production License Application Form includes the area of the site?
  The "production area" in the Application Form for medical device production License mainly includes the area of product processing, inspection sites, storage sites, etc。"Purification area" mainly refers to the area of production area and inspection area with cleanliness requirements, and "storage area" mainly refers to the storage area of raw material warehouse, semi-finished products, finished products warehouse, etc。The area indicated above should be consistent with the area indicated on the submitted plan。
  87, the application for the "medical device production license" related matters need to submit the information what matters needing attention?
  A: Note the following:
  (1) If the application materials to be submitted for licensing are repeated, do you need to submit multiple copies?
  It isn't necessary。For example, when applying for the issuance of the Medical Device Production License, if the person in charge of the enterprise is also the person in charge of production, you only need to submit a copy of your identity certificate。
  (2) To apply for the issuance of the Medical Device Production License, it is necessary to submit a list of educational qualifications and professional titles of employees in production management positions, and whether the employees in production management positions are responsible for production?
  不是。The production management personnel here refers to all personnel engaged in production activities in the production department of the enterprise。
  (3) What are the supporting documents of the production site?
  Mainly includes lease agreement and proof of property (or proof of use)。Among them, the lease agreement (including attachments) should at least reflect the detailed address of the leased venue (such as: Room ×× Floor ××, No. ×× Road ××, ×× District, Beijing), use, and contract validity, and the lease agreement signed with the property should provide a valid power of attorney issued by the property owner。The real estate certificate shall comply with the requirements of laws and regulations and the relevant provisions of Beijing, and the housing ownership certificate or real estate title certificate shall be applied for, and the planning use recorded in the housing ownership certificate or real estate title certificate shall be consistent with the use of medical device production activities。Residential buildings cannot be used as production sites for enterprises。For those who have not obtained the housing ownership certificate or the real estate title certificate, the proof of the right to use shall be submitted, such as the construction project planning license issued by the competent department of planning and natural resources and the certificate issued by the people's government at or above the township that can be used to produce medical devices。
  (4) What matters should be included in the business scope of the Business License?
  The business scope of the "Business license" submitted by the enterprise when applying for the second and third class medical device production license should generally be included in the newly established enterprises engaged in medical software development in Chaoyang District, Haidian District, Fengtai District, Shijingshan District and the urban sub-center,The business scope of the business license may include "production of Class II and Class III medical devices (limited to medical software development)".。
  (5) Whether the application for the issuance of the Medical Device Production License needs to submit a complete quality manual?
  需要。Enterprises are required to submit a complete copy of the Quality Manual during the bidding process。
  (6) What are the requirements of the qualified test report of the clean room?
  The test report should be a qualified test report in accordance with the "Sterile Medical Device Production Management Practice" (YY0033), and if a third party is commissioned to test, the third party should have the corresponding qualification。The test address in the test report should be consistent with the production address, purification area, plant layout, etc. filled in the Medical Device Production License Application Form。
  (7) What are the requirements of the layout of the main production workshop?
  The layout of the main production workshop should be in accordance with the process flow, indicating the function and area of each area, among which the layout of the purification workshop should also indicate the function room, area, and flow of people and logistics。If the production workshop has multiple rooms, the layout plan shall indicate the room number of each room。
  (8) If there are any requirements on the location roadmap and general plan of the plant?
  The location map of the plant should indicate the location, the main buildings around the site and other information;The general plan of the plant shall include all production addresses such as production, inspection and warehouse, indicating the function and area of each area。
  (9) What are the requirements of the process flow chart?
  The process flow chart should indicate the main control items and control points in accordance with the actual process, including the description of the equipment, personnel and process parameters control of key processes and special processes, and the process with special requirements for the environment should be labeled and explained separately。
  (10) What are the requirements for electronic documents of application materials?
  The electronic version of the application materials shall be consistent with the paper version. Each electronic document shall be in PDF format and shall not be larger than 10M。
  The fifth classification definition
  88, medical device classification definition application document requirements, specific location on the official website of the Beijing Drug Administration ?
  A: Beijing Municipal Drug Administration website → Special columns → Medical device registration and supervision → Medical device registration review, file name: "Beijing Medical Device Classification Definition Declaration Requirements"。
  89, medical device classification defines the application document delivery address ?
  A: Applications can be submitted in person or by mail on Mondays or Thursdays of each week。Address: Project Management Department, Beijing Medical Device Evaluation and Inspection Center, No.13 Shuiche Hutong, Xicheng District, Beijing, China, Tel: 83979949。
  90, online declaration of medical device classification location ?
  A: The applicant enters the page of "Medical Device Classification and Definition Information System" of the secondary website of "Medical Device Standard Management Center of National Drug Administration" through the website of China National Institute of Food and Drug Control (http:// app).nifdc.org.cn/biaogzx/login.do?formAction=login&systemType=2) Register online, fill in the Classification Definition Application Form after registration, and upload other application materials。
  91, medical device classification definition submission information description ?
  A: The information submitted for the classification of medical devices is described as follows:
  (1) Application for classification and definition。Should be signed by the legal representative or person in charge and stamped with the official seal, if not registered by the Industrial and Commercial Bureau, should provide "Notice of pre-approval of enterprise name" and other supporting documents, and the proposed legal representative in the application form signed and dated。
  (2) Product photos and/or product structure drawings。
  (3) Product technical requirements and preparation instructions。
  (4) Instructions for use。
  (5) Information related to new products (if any) shall include:
  a.Analysis and comparison with the relevant products in the listed products, classification catalogue or classification definition notification document, and explain that the newly developed products have not been included in the classification catalogue judgment principles;
  b.Review of academic papers, monographs and documents published in core journals that can fully explain the clinical application value of the product;
  c.Product innovation content;
  d.A novelty search report issued by an information or patent search institution;
  e.Other relevant supporting materials。
  (6) A self-assurance statement of the authenticity of the submitted information, and a commitment to bear legal responsibility if the material is false。
  (7) Other materials related to product classification。
  (8) When reporting information, it is not the legal representative or responsible person himself, shall submit a Power of attorney。
  92, medical device classification definition application data requirements?
  Answer: Medical device classification application data requirements:
  (1) The application materials shall be true, complete, clear and clean, stamped with the official seal of the enterprise, and those required to sign must sign。
  (2) The forms completed by the applicant and the application materials prepared should be A4 size paper, and the original documents issued by the government and other institutions should be provided in full size。
  (3) Where a copy of the application materials should be submitted, the copy should be clear, and the date should be marked on the copy, stamped with the official seal of the enterprise。
  (4) The left margin of the application materials should generally be greater than 20mm (for file binding)。
  (5) The same items in the application materials should be filled in the same。
  93. Medical device classification defines time limit requirements?
  A: The classification of medical device products should be completed within 10 working days from the date of receiving the application materials (excluding the receipt and delivery period), and the time required for supplementary information is not counted。
  Beijing Medical Device Evaluation and Inspection Center within 7 working days from the date of receiving the application materials,Completion of technical review,Where the application materials do not meet the examination standards and need to be modified,Put forward the corresponding supplementary amendments,Give to the applicant,Signed and dated by both parties (the time for supplementary materials is not included in the review period)。For those who meet the review standards after revising the supplementary materials, issue technical review opinions after completion of the review, fill in the "Classification Definition Approval Form", and submit the relevant technical review opinions and application materials to the Medical Device Registry of the Beijing Municipal Drug Administration (hereinafter referred to as the Municipal Bureau of Devices).。
  The equipment department of the Municipal Bureau shall complete the examination and approval of the classification and definition within 3 working days from the date of receipt of the application materials。The classification definition review can determine the product category,Inform the applicant of the classification result directly in the classification information system;Where classification cannot be determined by the classification definition review,Pre-classification comments should be confirmed, The relevant materials will be sent to the Medical Device Standard Management Center of the State Drug Administration within 2 working days。
  94, medical device classification documents annual summary online address?
  A: Home Page → Office Hall → Medical device standard and classification management → Medical device classification and definition information system → Summary of classification and definition results。
  95, registered enterprises outside Beijing can apply for medical device classification in the Beijing Municipal Drug Administration?
  Answer: No, each province is responsible for the enterprises in their respective jurisdictions to apply for device classification。
  96, when applying for classification, it is necessary to design and develop samples?
  A: When applying for the classification of medical devices, product samples must be designed and developed。
  97, "Medical device product classification definition registration Form" how to fill in the intended use column?
  A: The intended use of the product directly affects the classification of the product, it is recommended that the enterprise clearly describe the intended use of the product, the applicable population, the use of the location environment, contraindications and other content。
  98, "Medical device product classification definition registration Form" how to fill in the main risk points column?
  Answer: Mainly fill in the product in the clinical normal use of patients, operators, the surrounding environment may cause damage, the applicant can refer to the requirements of YY0316 standard, risk assessment analysis。
  99, the applicant has uploaded the classification definition information can be modified again?
  A: At present, the applicant for the classification of medical devices is not allowed to modify the information after uploading it。
  100, the classification of medical devices, what are the main information uploaded online?
  A: The main data requirements include product specifications, product photos and/or product structure diagrams, product technical requirements, product new development judgment basis (not yet included in the "Classification Catalogue"), academic papers, monographs and document reviews of product clinical application value, product innovation content (if any) and other data requirements。
(2022/7/25 14:17:35 Read 5121 times)

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