The State Food and Drug Administration issued the "Guidelines for Compilation of Technical Requirements for Medical Device Products"

On February 9, the State Food and Drug Administration issued an announcement stating that in order to improve the standardization and scientificity of medical device technical review, and to guide medical device registrants/filers to prepare product technical requirements, in accordance with the "Medical Device Supervision and Administration Regulations" and " In accordance with the provisions of the Administrative Measures for the Registration and Filing of Medical Devices and the Administrative Measures for the Registration and Filing of In Vitro Diagnostic Reagents, the Food and Drug Administration organized the revision of the Guiding Principles for Compilation of Technical Requirements for Medical Device Products, which are hereby issued

Annex: Guidelines for Compilation of Technical Requirements for Medical Device Products

In order to improve the normative and scientific nature of the technical review of medical devices, and to guide the registrant/filer of medical devices in the preparation of product technical requirements, according to the Regulations on the Supervision and Administration of Medical Devices, the Administrative Measures for Medical Device Registration and Filing, and the In Vitro Diagnostic Reagents Registration and Filing Management Regulations, etc.

1.

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 specify specific requirements for specific products

2.

(1) The preparation of product technical requirements shall comply with relevant national laws and regulations

(2) The technical requirements of products shall adopt standardized and general terms

(3) In principle, the number of each content of the inspection method in the product technical requirements should correspond to the number of each content of the performance index

(4) The characters, numbers, formulas, units, symbols, charts, etc.

(5) If the content in the product technical requirements refers to national standards or industry standards, the serial number and date of the corresponding standard shall be indicated

3.

The content of product technical requirements generally includes product name, model, specification and its division description (if necessary), performance index, inspection method, term (if applicable) and appendix (if applicable)

(1) Product name

The product name in the product technical requirements should be in Chinese and be consistent with the product name applied for registration or filing

(2) Models, specifications and descriptions of their divisions

The product model and specifications should be specified in the product technical requirements

For products containing software, the naming rules of software release version and software full version should be clarified

(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 judged
.

Items that do not have a substantial impact on product safety and effectiveness may not be listed in the technical requirements performance indicators
.
For example, some drainage catheter products mainly focus on their smoothness.
The product needs to be able to effectively connect the suction device and the end of use, and ensure that the connection is firm.
If necessary, the diameter and length of the catheter can be used as product descriptive information in the appendix of technical requirements.
Not as a product performance indicator
.
Others such as product engineering drawings 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 performance indicators, such as the length and outer diameter of vascular stent products, and the dimensional tolerance of orthopaedic implants
.

2.
The formulation of the performance indicators in the technical requirements can refer to the relevant national standards/industry standards, combined with the design characteristics and intended use of specific products, and should comply with the mandatory national/industry standards applicable to the products
.
If the product structure features, intended use, usage, etc.
are inconsistent with the scope of application of the mandatory standards, the registrant/filer shall make a statement that the mandatory standards are not applicable, and provide relevant information
.

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

(4) Inspection method

The inspection method is a method used to verify whether the product meets the specified requirements, and the formulation of the inspection method should be adapted to the corresponding performance indicators
.
Test methods using applicable established standard methods should be prioritized and, if necessary, methodological validation should be performed to ensure the reproducibility and operability of the test methods
.

In general, the test method should include the test procedure and the presentation of the results (such as calculation method, etc.
)
.
If necessary, all conditions, steps, etc.
to ensure reproducible results can also be added to the test principle, sample preparation and storage, instruments,
etc.

For in vitro diagnostic reagent products, the test method should also clearly state the reference substance/standard substance used, the sample preparation method, the number of tests, and the calculation method
.

(5) Appendix

For the third category of in vitro diagnostic reagent products, the main raw materials and production process requirements shall be specified in the form of an appendix in the product technical requirements
.

For medical device products, if necessary, some descriptive characteristics can be indicated in the appendix in more detail, such as product sterilization or non-sterile supply status, product validity period, main raw materials, production process, product main safety features, Key technical specifications, key component information, MRI compatibility, and more
.

(6) The product technical requirement number is the registration certificate number (record number) of the corresponding product
.
The product technical requirement number to be registered (recorded) can be left blank
.

Fourth, performance requirements

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

Indicators that can be objectively judged usually refer to indicators that can be quantified or objectively described
.
For example, the indicator can be directly checked by a certain test method that can verify its characteristic value, and the data result can be obtained directly
.

For example, the important function of hemodialyzer products is the removal of target substances, and the effect achieved by this function can be directly verified by measuring the remaining amount of the removed target substances, so it should be specified in the technical requirements to characterize its main functionality; intravascular Catheter products are required to be kept leak-free during use.
Therefore, the technical requirements should specify the performance requirements of the product without leakage, and provide objective and scientific test methods to ensure that the product has no leakage under the specified conditions; important functions of the infusion pump The characteristic indicators are the infusion flow rate and the corresponding accuracy.
The above indicators should be specified in the technical requirements, and the verification should be carried out according to the specified methods to ensure the effective application of the product in the clinic; the imaging resolution of imaging ultrasonic diagnostic equipment is an important technology for image quality.
The index should be specified in the technical requirements, and an objective and scientific test method should be given to ensure that the product performance meets its declared functional requirements
.

The following contents are not recommended to be specified in the technical requirements performance indicators:

(1) Research and evaluation content

The research content is generally a combination of experiments and analysis to study the characteristics of a product, and is usually a verification activity to determine a specific attribute of the product during the product design and development stage
.

For example, the shelf life of a medical device refers to the period during which the final product of a medical device can perform its intended function normally.
In the product design and development stage, a study on the shelf life of the product needs to be completed
.
For passive medical device products, aging test conditions, such as temperature, humidity, etc.
, need to be set for validity study, and aging test is carried out, and is calculated and determined according to the set aging conditions and the data of product performance and packaging performance after aging.
its shelf life
.
For active medical devices, the use status of the product can be listed, the clinical use situation can be completely analyzed, and the aging test of the product can be directly studied; the product (system) can also be decomposed into different subsystems/components for evaluation.
The decomposition relationship should be analyzed in detail, and on this basis, the service life of the product should 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 validation studies, fatigue studies, in vitro degradation studies, human factor validation studies, reliability validation studies, magnetic resonance compatibility studies,
etc.

Evaluative content generally refers to an evaluation of the suitability, adequacy and/or effectiveness of a product for its stated objectives
.
This kind of evaluation can use multiple test combinations for comprehensive evaluation, or can use other methods (such as historical data, marketed product information, etc.
) for evaluation
.

For example, biocompatibility research (including material-mediated heatogens) is generally considered to be an evaluation project, and a combination of multiple biological tests can be used for comprehensive evaluation, or historical data, marketed product information and other data can be used.
The comparison method can be used for evaluation, and the chemical analysis method can also be used to determine the toxicological data
.

For another example, the environmental requirements of medical electrical appliances are to evaluate the adaptability of products in various working environments and simulated storage and transportation environments, which are generally considered to be stability evaluation items
.
Different climatic environmental conditions and mechanical environmental conditions can be formulated for testing, or the condition of the whole machine can be evaluated by testing key components, or it can be judged by comparing similar products on the market
.

Other evaluation items also include virus inactivation effect evaluation, immunogenicity evaluation and so on
.

(2) Contents related to non-finished products

The technical requirements stipulate the relevant performance of the finished products, and the performance indicators and characteristics of raw materials and semi-finished products are generally not recommended to be reflected in the technical requirements
.
For example, the mechanical properties and chemical properties of some raw materials
.

5.
Format requirements

See attached for the format of technical requirements for medical device products
.

Attachment: Format of Technical Requirements for Medical Device Products

attached

Format of technical requirements for medical device products

Medical device product technical requirement number: (Song->

Product name (Singapore small No.
2, bold)

1.
Product model/specification and its division description (Song->

1.
1 …… (Song Ti No.
4)

1.
1.
1  …

.
.
.

2.
Performance Indicators

2.
1 …… (Song Ti No.
4)

2.
1.
1  …

.
.
.

3.
Inspection method (Song->

3.
1 …… (Song Ti No.
4)

3.
1.
1  …

.
.
.

4.
Terminology (California small four, bold) (if applicable)

4.
1 …… (Song Ti No.
4)

4.
2 .
.
.

.
.
.

(pagination)

APPENDIX A  …

A1.
…… (Song Ti No.
4)

A1.
1  …

Note:

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

2.
Do not add unspecified contents such as cover, registrant's name and logo, signature, etc.

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