In order to improve the standardization and scientific nature of the technical review of medical devices, and to guide medical device registrants/filers in drafting product technical requirements, this guideline is formulated in accordance with the provisions of the "Regulations on the Supervision and Administration of Medical Devices", "Measures for the Registration and Filing of Medical Devices", and "Measures for the Registration and Filing of In Vitro Diagnostic Reagents", among others.

I. Scope of Application

This guideline applies to medical device products that apply 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, without specifying the specific requirements for specific products. The examples given in the guideline are for reference only, and relevant regulatory agencies and registrants/filers should refine them according to specific circumstances.

II. 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 general terminology. If special terminology is involved, clear definitions must be provided and included in the "4. Terminology" section. If terminology from relevant standards or guidelines is directly adopted, it does not need to be repeated in the technical requirements "4. Terminology" section. Custom terms that change the original meaning but have the same name as the above terms should not be used.

(3) The numbering of the contents of inspection methods in the product technical requirements should correspond to the numbering of the performance indicators.

(4) The text, numbers, formulas, units, symbols, charts, etc. in the product technical requirements should comply with relevant standardization requirements.

(5) If the content in the product technical requirements references national standards or industry standards, the corresponding standard number and year should be indicated.

III. Main Content

The content of product technical requirements generally includes product name, model, specifications and their classification 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) Model, Specifications and Their Classification Description

The product technical requirements should clearly specify the product model and specifications. For products with multiple models and specifications within the same registration unit, the classification description of different models and specifications should be clearly stated (it is recommended to use illustrations and/or tables), and content with more textual descriptions can be listed in the appendix.

For products that include software, the software release version and naming rules for the complete software version should be clearly specified.

(3) Performance Indicators

1. The performance indicators in the product technical requirements refer to the functional and safety indicators of the finished product that can be objectively determined.

Items that do not have a substantial impact on the safety and effectiveness of the product may not be listed in the performance indicators of the technical requirements. For example, some drainage catheter products mainly focus on their patency, and the product needs to effectively connect to the suction device and the usage end, ensuring a secure connection. Information such as the diameter and length of the catheter may be included as descriptive information in the technical requirements appendix rather than as performance indicators. Other items such as product engineering drawings do not need to be listed in the technical requirements.

However, certain product size information may have a significant impact on their safety and effectiveness, and should be specified in the performance indicators of the technical requirements, such as the length and outer diameter of vascular stent products, and the dimensional tolerances of orthopedic implants.

2. The formulation of performance indicators in the technical requirements can refer to relevant national standards/industry standards and combine the specific design characteristics and intended use of the product, and should comply with the applicable mandatory national standards/industry standards. If the structural characteristics, intended use, and usage methods of the product are inconsistent with the scope of application of the mandatory standards, the registrant/filers should provide an explanation for the non-application of the mandatory standards and provide relevant materials.

3. The performance indicators in the product technical requirements should specify concrete requirements and should not be provided in the form of "see attached materials" or "according to the supply contract".

(4) Inspection Methods

Inspection methods are used to verify whether the product meets the specified requirements, and the formulation of inspection methods should correspond to the relevant performance indicators. Priority should be given to using applicable established standard methods for inspection, and if necessary, methodological validation should be conducted to ensure the reproducibility and operability of the inspection methods.

Generally, the inspection methods should include descriptions of the test steps and results (such as calculation methods, etc.). If necessary, additional content such as test principles, sample preparation and preservation, instruments, and all conditions and steps to ensure reproducibility of results may be included.

For in vitro diagnostic reagent products, the inspection methods should also clearly specify the reference materials/standard materials used, sample preparation methods, number of tests, and calculation methods.

(5) Appendices

For Class III in vitro diagnostic reagent products, the product technical requirements should clearly specify the main raw materials and production process requirements in the form of appendices.

For medical device products, if necessary, certain descriptive characteristics can be more detailed in the appendix, such as the sterilized or non-sterilized supply status of the product, product validity period, main raw materials, production processes, main safety features of the product, key technical specifications, key component information, magnetic resonance compatibility, etc.

(6) The product technical requirements number is the corresponding product registration certificate number (filing number). The number for the product technical requirements to be registered (filed) can be left blank.

IV. Performance Indicator Requirements

According to the "Measures for the Registration and Filing of Medical Devices" and "Measures for the Registration and Filing of In Vitro Diagnostic Reagents", the performance indicators in the technical requirements refer to the functional and safety indicators of the finished product that can be objectively determined.

Objectively determinable indicators usually refer to quantifiable or objectively describable indicators. For example, the indicator can be directly tested through a specific and verifiable test method, and data results can be directly obtained.

For example, the important function of blood dialysis products is the removal of target substances, and the effectiveness of this function can be directly verified by measuring the remaining amount of the target substance removed, so it should be specified in the technical requirements to characterize its main functionality; vascular catheter products require that they must remain leak-free during use, so the technical requirements should specify the performance requirements for no leakage and provide objective, scientific test methods to ensure no leakage under specified conditions; the important functional indicators of infusion pumps are infusion flow rate and corresponding accuracy, which should be specified in the technical requirements, and verification should be conducted according to specified methods to ensure effective clinical application of the product; the imaging resolution of ultrasound diagnostic equipment is an important technical indicator of image quality, which should be specified in the technical requirements, along with objective, scientific test methods to ensure that the product performance meets its claimed functional requirements.

The following content is not recommended to be specified in the performance indicators of the technical requirements:

1. Research and Evaluation Content

Research content generally refers to a combination of experiments and analyses conducted to study product characteristics, usually carried out during the product design and development phase to verify a specific attribute of the product.

For example, the shelf life of medical devices refers to the period during which the medical device can perform its intended function. Research on the shelf life must be completed during the product design and development phase. For non-active medical devices, the shelf life study must set aging test conditions, such as temperature and humidity, conduct aging tests, and calculate and determine the shelf life based on the established aging conditions and data on product performance, packaging performance, etc. For active medical devices, the product can be analyzed in terms of usage conditions, and a complete analysis of clinical usage can be conducted, directly performing aging test research on the product; alternatively, the product (system) can be decomposed into different subsystems/components for evaluation, with a detailed analysis of the decomposition relationship. Based on this, different decomposition methods (such as dividing the product into key components and non-key components) can be used to determine the product's service life.

In addition, other research content includes sterilization validation studies, fatigue studies, in vitro degradation studies, human factors validation studies, reliability validation studies, magnetic resonance compatibility studies, etc.

Evaluation content generally refers to the assessment of the appropriateness, sufficiency, and/or effectiveness of the product's specified objectives. This evaluation can be conducted using multiple experimental combinations for a comprehensive assessment or through other means (such as historical data, information on marketed products, etc.).

For example, biocompatibility studies (including material-mediated pyrogens) are generally considered evaluation projects, which can be assessed using multiple biological test combinations for a comprehensive evaluation, or various data such as historical data and information on marketed products can be used for comparison-based evaluation. Chemical analysis methods combined with toxicological data can also be used for determination.

Similarly, the environmental requirements for medical electrical equipment evaluate the product's adaptability in various working environments and simulated storage and transportation environments, which is generally considered a stability evaluation project. Different climatic and mechanical environmental conditions can be established for testing, or the overall condition can be evaluated through tests on key components, or judgments can be made through comparisons with similar products already on the market.

Other evaluation projects also include evaluations of virus inactivation effects, immunogenicity evaluations, etc.

2. Non-Finished Product Related Content

Technical requirements specify the performance related to finished products, and 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, chemical properties, etc., of certain raw materials.

5. Format Requirements
    The format for technical requirements of medical device products is provided in the appendix.

    Appendix: Format for Technical Requirements of Medical Device Products

Appendix

Format for Technical Requirements of Medical Device Products

Technical requirements number for medical device products:(SimSun, small size 4, bold)

Product Name (SimSun, small size 2, bold)

1. Product Model/Specification and its Classification Description (SimSun, small size 4, bold) (if applicable)

1.1 …… (SimSun, small size 4)

1.1.1 ……

……

2. Performance Indicators (SimSun, small size 4, bold)

2.1 …… (SimSun, small size 4)

2.1.1 ……

……

3. Testing Methods (SimSun, small size 4, bold)

3.1 …… (SimSun, small size 4)

3.1.1 ……

……

4. Terminology (SimSun, small size 4, bold) (if applicable)

4.1 …… (SimSun, small size 4)

4.2 ……

……

(Page break)

Appendix A …… (SimSun, small size 4, bold) (if applicable)

A1. …… (SimSun, small size 4)

A1.1 ……

Note:

1. For content involving Western fonts, Times New Roman font can be used.

2. Do not add unregulated content such as covers, registrant names and logos, signatures, etc.

3. Page numbers can be in the form of x (page x)/y (total pages), such as 1/9.