In order to improve the standardization and scientific nature of medical device technical review and guide medical device registrants/filers in writing product technical requirements, in accordance with the provisions of the “Medical Device Supervision and Administration Regulations”, “Medical Device Registration and Filing Management Measures” and “In Vitro Diagnostic Reagent Registration and Filing Management Measures”, the State Food and Drug Administration organized and revised the “Guiding Principles for the Preparation of Technical Requirements for Medical Device Products”, which was recently released.
The following is the original text of the “Guiding Principles for Writing Technical Requirements for Medical Device Products”:
Guidelines for writing technical requirements for medical device products
In order to improve the standardization and scientific nature of medical device technical review and guide medical device registrants/filers in the preparation of product technical requirements, these guiding principles are formulated in accordance with the “Medical Device Supervision and Administration Regulations”, “Medical Device Registration and Filing Management Measures”, “In Vitro Diagnostic Reagents Registration and Filing Management Measures” and other regulations.
1. Scope of application
This guideline applies to medical device products applying for registration or filing, including in vitro diagnostic reagent products.
This guideline only provides general requirements for the format and content of technical requirements for medical device products and does not stipulate specific requirements for specific products. The examples given in the guidelines are for reference only and should be refined based on specific circumstances by relevant regulatory authorities and registrants/filers.
2. Basic requirements
(1) The preparation of product technical requirements should comply with relevant national laws and regulations.
(2) Product technical requirements should use standardized and common terminology. If special terms are involved, a clear definition must be provided and written in the “4. Terminology” section. If terms in relevant standards, guidelines or other recognized terms are directly adopted, there is no need to list them repeatedly in the “4. Terminology” section of the technical requirements. Custom terms that have the same name as above but change the original meaning should not be used.
(3) In principle, the numbering of each item of inspection method in the product technical requirements should correspond to the numbering of each item of performance index.
(4) The words, numbers, formulas, units, symbols, charts, etc. in product technical requirements should comply with relevant standardization requirements.
(5) If the content in the product technical requirements cites national standards or industry standards, the number and year number of the corresponding standards should be indicated.
3. Main content
The content of product technical requirements generally includes product name, model, specification and division description (if necessary), performance indicators, inspection methods, terminology (if applicable) and appendices (if applicable).
(1) Product name
The product name in the product technical requirements should be in Chinese and consistent with the product name applied for registration or filing.
(2) Models, specifications and description of divisions
The product model and specifications should be clearly stated in the product technical requirements. For products with multiple models and specifications in the same registration unit, the division of different models and specifications should be clearly explained (diagrams and/or tables are recommended). Contents with more text can be listed in the appendix.
For products containing software, the naming rules for software release versions and complete software versions should be clear.
(3) Performance indicators
1. The performance indicators in the product technical requirements refer to the functionality and safety indicators of the finished product that can be objectively determined.
Items that do not have a substantial impact on product safety and effectiveness may not be listed in the technical requirements and performance indicators. For example, some drainage catheter products focus on their smoothness. The product needs to be able to effectively connect the suction device and the end of use, and ensure a firm connection. Information such as the diameter and length of the catheter can be used as product descriptive information in the technical requirements appendix when necessary, but not as product performance indicators. Others, such as product engineering drawings, etc., do not need to be listed in the technical requirements.
However, the dimensional information of some products will have an important impact on their safety and effectiveness and should be specified in the technical requirements and performance indicators, such as the length and outer diameter of vascular stent products, the dimensional tolerance of orthopedic implants, etc.
2. The performance indicators in the technical requirements can be formulated with reference to relevant national standards/industry standards and combined with the design characteristics and intended use of the specific product, and should comply with the mandatory national standards/industry standards applicable to the product. If the product’s structural characteristics, intended uses, usage methods, etc. are inconsistent with the applicable scope of the mandatory standards, the registrant/filer should provide an explanation for the inapplicability of the mandatory standards and provide relevant information.
3. The performance indicators in the product technical requirements should clearly specify the specific requirements and should not be provided in the form of “see attached information” or “according to the supply contract”.
(4) Inspection methods
The inspection method is a method used to verify whether the product meets the specified requirements. The formulation of the inspection method should be consistent with the corresponding performance indicators. Priority should be given to testing methods that use applicable established standard methods, and when necessary, methodological validation should be performed to ensure the reproducibility and operability of the testing methods.
Normally, the inspection method should include the test steps and the description of the results (such as calculation methods, etc.). If necessary, the test principles, sample preparation and storage, instruments, and all other conditions and steps to ensure reproducible results can be added.
For in vitro diagnostic reagent products, the test method should also clearly state the reference/standard material, sample preparation method, number of tests, and calculation method used.
(5) Appendix
For the third category of in vitro diagnostic reagent products, the product technical requirements should specify the main raw materials and production process requirements in the form of an appendix.
For medical device products, certain descriptive characteristics can be noted in the appendix in more detail when necessary, such as product sterilization or non-sterile supply status, product validity period, main raw materials, production processes, main product safety features, key technical specifications, key component information, magnetic resonance compatibility, etc.
(6) The product technical requirement number is the registration certificate number (filing number) of the corresponding product. The technical requirement number of the product to be registered (filed) can be left blank.
4. Performance index requirements
According to the “Registration and Filing Management Measures for Medical Devices”, the “Registration and Filing Management Measures for In Vitro Diagnostic Reagents” and other documents, the performance indicators in the technical requirements refer to the functionality and safety indicators of the finished product that can be objectively determined.
Indicators that can be objectively determined usually refer to indicators that can be quantified or objectively described.
For example, the indicator can be directly tested through a test method that is certain and can verify its characteristic value, and the data results can be obtained directly.
For example, the important function of a hemodialyzer product is the removal of target substances. The effect of this function can be directly verified by measuring the remaining amount of the removed target substance. Therefore, it should be specified in the technical requirements to characterize its main functionality; the intravascular catheter product requires that it must remain leak-free during use. Therefore, the technical requirements should stipulate the performance requirements of the product without leakage, and provide objective and scientific test methods to ensure that under specified conditions The product has no leakage; the important functional indicators of the infusion pump are the infusion flow rate and the corresponding accuracy. The above indicators should be stipulated in the technical requirements, and verification should be carried out according to the prescribed methods to ensure the effective application of the product in clinical practice; the imaging resolution of imaging ultrasonic diagnostic equipment is an important technical indicator of image quality. This indicator should be specified in the technical requirements, and objective and scientific test methods should be given to ensure that product performance meets its declared functional requirements.
The following content is not recommended to be specified in the technical requirements and performance indicators:
(1) Research and evaluation content
Research content is generally a combination of experiments and analyzes carried out to study product characteristics. It is usually a verification activity carried out to determine a specific attribute of the product during the product design and development stage.
For example, the shelf life of medical devices refers to the period of time to ensure that the final medical device product can perform its expected functions normally. Product shelf life research needs to be completed during the product design and development stage. For passive medical device products, the validity period study requires setting aging test conditions, such as temperature, humidity, etc., conducting aging tests, and calculating and determining the shelf validity period based on the set aging conditions and aging product performance, packaging performance and other data. For active medical devices, the usage status of the product can be enumerated, the clinical use situation can be fully analyzed, and the aging test of the product can be directly conducted; the product (system) can also be decomposed into different subsystems/components for evaluation. The decomposition relationship should be analyzed in detail. On this basis, the service life of the product can be determined through different decomposition methods (such as dividing the product into key components and non-critical components, etc.).
In addition, other research contents include sterilization verification research, fatigue research, in vitro degradation research, human factors verification research, reliability verification research, magnetic resonance compatibility research, etc.
Evaluative content generally refers to the evaluation of the suitability, adequacy and/or effectiveness of the product’s stated goals. This kind of evaluation can either use multiple test combinations for comprehensive evaluation, or use other methods (such as historical data, marketed product information, etc.) for evaluation.
For example, biocompatibility studies (including material-mediated pyrogens) are generally considered to be evaluative projects. Multiple biological test combinations can be used for comprehensive evaluation. Historical data, marketed product information and other data can also be used for evaluation by comparison. Chemical analysis methods can also be used in conjunction with toxicological data for determination.
For another example, the environmental requirements for medical electrical appliances are to evaluate the adaptability of products in various working environments and simulated storage and transportation environments. They are generally considered to be stability evaluation items. Different climatic and mechanical environmental conditions can be formulated for testing, or the condition of the entire machine can be evaluated by testing key components, or judgment can be made by comparing similar products on the market.
Other evaluation projects also include virus inactivation effect evaluation, immunogenicity evaluation, etc.
(2) Content related to non-finished products
The technical requirements stipulate the relevant performance of the finished product. It is generally not recommended to reflect the performance indicators and characteristics of raw materials and semi-finished products in the technical requirements. For example, the mechanical properties and chemical properties of certain raw materials.
5. Format requirements
The format of technical requirements for medical device products is attached.
Attached: Medical device product technical requirements format
attached
Medical device product technical requirements format
Medical device product technical requirements number: (Song 4 in Song font, bold)
Product name (Song 2nd size in Song font, bold)
1. Product model/specification and description of its division (Song font size 4, bold) (if applicable)
1.1…(Song font size 4)
1.1.1…
…
2. Performance indicators (Song font size 4, bold)
2.1…(Song font size 4)
2.1.1…
…
3. Inspection method (Song 4 size in Song font, bold)
3.1…(Song font size 4)
3.1.1…
…
4. Terminology (Song font size 4, bold) (if applicable)
4.1…(Song font size 4)
4.2…
…
(pagination)
Appendix A…(Song font size 4, bold) (if applicable)
A1. ……(Small 4 in Song font)
A1.1……
Note:
1. Times New Roman font can be used for content involving Western fonts.
2. Do not add cover, registrant name and logo, signature and other unstipulated content
3. The page number can be in the form of x (page x)/y (total page number), such as 1/9
