Medical device product technical requirements number for the corresponding registration certificate number (record number). To be registered (for the record) of the product technical requirements number can be left blank.
Basic requirements
(a) the preparation of medical device product technical requirements should be consistent with relevant state laws and regulations.
(B) medical device product technical requirements should be standardized, common terminology. If it involves special terms, need to provide clear definitions, and write to the "4.Terminology" section.
(C) the technical requirements of medical devices in the test method of the content of the number should in principle and the performance indicators of the content of the number corresponds to.
(d) medical device product technical requirements in the text, numbers, formulas, units, symbols, charts and other standardized requirements.
(E) such as medical device product technical requirements in the content of the national standards, industry standards or the Chinese Pharmacopoeia, should ensure its validity, and indicate the number of the corresponding standard and the number of years and the Chinese Pharmacopoeia version number
Extended information
Medical device product technical requirements of the content should be in line with the following requirements:< /p>
(a) Product name. Product technical requirements of the product name should be used in Chinese, and with the application for registration (for the record) of the Chinese name of the product is consistent.
(ii) product type / specification and its division of instructions. Product technical requirements should be clear product model and / or specifications, as well as its division of instructions.
On the same registration unit there are a variety of models and / or specifications of the product, it should be clear that the model and all the differences between the specifications (if necessary, the corresponding illustrations can be attached to illustrate). For model/specification of the expression of the larger text can be provided in the form of an appendix.
(C) performance indicators.
1, the product technical requirements of the performance indicators refers to the objective determination of the finished product functionality, safety indicators and other indicators related to quality control. Product design and development of evaluative content (such as biocompatibility evaluation) is not formulated in principle in the product technical requirements.
2, product technical requirements in the development of performance indicators should refer to the relevant national standards/industry standards and specific product design features, intended use and quality control level and should not be lower than the applicable mandatory national standards/industry standards.
3, the product technical requirements of the performance indicators should be clear and specific requirements, should not be "see attached information", "according to the supply contract" and other forms of provision.
(d) test methods. The development of test methods should be adapted to the corresponding performance indicators. Priority should be given to the use of recognized or standard test methods have been promulgated. The development of test methods need to ensure that the reproducibility and operability, the need to specify the preparation of samples, if necessary, can be accompanied by the appropriate illustrations to illustrate the larger text can be provided in the form of appendices.
For in vitro diagnostic reagent products, test methods should also clearly state the use of reference/standard products, sample preparation methods, the use of reagents and the number of batches, the number of tests, calculation methods.
(E) for the third category of in vitro diagnostic reagent products, product technical requirements should be clear in the form of an appendix to the main raw materials, production processes and semi-finished products requirements.
(F) medical device product technical requirements number for the corresponding registration certificate number (record number). To be registered (for the record) the technical requirements of the product number can be left blank.
State Food and Drug Administration - Guidelines for the preparation of technical requirements for medical device products