NMPA Product Technical Requirements Support

Product technical requirements

Product technical requirements are one of the most important documents in medical device registration and are implemented throughout the entire life cycle of medical devices. To open a product registration application, writing product technical requirements is the first prerequisite.

The quality of product technical requirements can be directly related to the true status of the product. Because when a product is submitted for inspection, the product technical requirements document must be submitted firstly. The document will involve all performance indicators, inspection methods and appendix information requirements of the product submitted for inspection, so as to check whether it is compiled and formulated in compliance with the requirements of national and industry standards. During the product inspection process, it must be continuously polished until it completely meets the requirements for the final product inspection report.

Moreover, all registration documents will also be compiled around the product technical requirements. After submission for review, the reviewer will focus on reviewing and analyzing the company’s product technical requirements, which shows that the importance of writing a good product technology.

In order to improve the standardization and scientificity of technical evaluation of medical devices to guide medical device registrants/filers to prepare product technical requirements, the National Medical Products Administration organized the revision of the “Guiding Principles for Writing Technical Requirements for Medical Device Products” (No. 8, 2022) in accordance with the provisions of the “Medical Device Supervision and Administration Regulations”, “Medical Device Registration and Management Measures” and “In Vitro Diagnostic Reagents Registration and Filing Management Measures”. In the process of writing product technical requirements, it is very important to understand its key points and difficulties. Based on the “Guiding Principles for Writing Product Technical Requirements”, we have compiled several key points as follows:

Basic requirements for writing product technology:

The preparation of technical requirements for medical device products should comply with relevant national laws and regulations;
Standard and common terminology should be used in technical requirements for medical device products. If special terms are involved, a clear definition must be provided and written in the “4. Terminology” section;
In principle, the numbers of each item of inspection methods in the technical requirements for medical device products should correspond to the numbers of each item of performance indicators;
The characters, numbers, formulas, units, symbols, charts, etc. in the technical requirements of medical device products should comply with standardization requirements;
If the content in the technical requirements of medical device products cites national standards, industry standards or the Chinese Pharmacopoeia, its validity should be guaranteed, and the number and year of the corresponding standard and the version number of the Chinese Pharmacopoeia should be noted.

Content requirements for writing product technology:

Product name: The product name in the product technical requirements should be in Chinese and consistent with the Chinese product name applied for registration (filing).
Product model/specification and description of its division: The product model and/or specification and description of its division should be clearly stated in the product technical requirements. For products with multiple models and/or specifications in the same registration unit, all differences between each model and specification should be clarified (corresponding illustrations can be attached if necessary). If the description text of the model/specification is larger, it can be provided in the form of an appendix.
Performance indicators:

The performance indicators in the product technical requirements refer to the functionality, safety indicators and other quality control-related indicators of the finished product that can be objectively determined. In principle, evaluative content in product design and development (such as biocompatibility evaluation) is not specified in product technical requirements.
The performance indicators in product technical requirements should be formulated with reference to relevant national standards/industry standards and combined with the design characteristics, intended use and quality control level of the specific product, and should not be lower than the mandatory national standards/industry standards applicable to the product.
The performance indicators in the product technical requirements should clearly state the specific requirements and should not be provided in the form of “see attached information” or “according to the supply contract”.

Inspection method:

The formulation of inspection methods should be adapted to the corresponding performance indicators. Priority should be given to the use of recognized or promulgated standard inspection methods. The formulation of the test method must ensure reproducibility and operability. If necessary, the sample preparation method must be clarified. If necessary, corresponding diagrams may be attached for explanation. If the text is large, it may be provided in the form of an appendix.

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

For the third category of in vitro diagnostic reagent products, the product technical requirements should specify the main raw materials, production processes and semi-finished product requirements in the form of an appendix.
The technical requirement number for medical device products is the corresponding medical device registration certificate number (filing number). The technical requirement number of the product to be registered (filed) can be left blank.