A medical device product registration certificate is how to handle?

The following is learned from the Aojida medical equipment. The relevant documents are & lt; medical device registration management methods & gt;, which made detailed provisions, now give you the original text for reference: Article V domestic enterprises for the registration of the first class of medical devices for production, shall submit the following materials: (a) medical device manufacturer qualification certificate. (B) registered product standards and preparation instructions. (C) product full performance self-test report. (D) the enterprise product production of existing resource conditions and quality management capabilities (including testing methods) of the description. (E) product instructions. (F) Self-assurance statement of the authenticity of the submitted materials. Article domestic enterprises to produce the second class, the third class of medical devices trial production registration shall submit the following materials: (A) medical device manufacturer qualification certificate. (B) product technical reports. (C) safety risk analysis report. (D) registered product standards and preparation instructions. (E) product performance self-test report. (F) State Drug Administration-recognized medical device quality testing organizations within the past year (biological materials for clinical trials within six months before) issued by the product trial production registered type test report. (G) more than two clinical trial sites of clinical trial reports. The report provides the implementation of the "medical device registration clinical trial report sub-provisions" (see Appendix), clinical trials to implement the "Medical Device Product Clinical Trial Management Measures". (H) product instructions. (Ix) the submitted material authenticity of the self-assurance statement. Article 7 Domestic enterprises to produce the second class, the third class of medical devices quasi-production registration shall be submitted to the following materials: (a) medical device manufacturer qualification certificate. (B) A copy of the trial production registration certificate. (C) registered product standards. (D) trial production during the product improvement report. (E) enterprise quality system assessment (certification) of valid documents. (F) the State Drug Administration recognized medical device quality testing organizations within the past year issued by the product type test report for production registration. (G) product quality tracking report. (H) the authenticity of the materials submitted to the self-assurance statement. Aojida medical devices in the organization only focus on medical devices.