(1) The applicant's corporate legal person qualification certificate.
(2) Product intellectual property rights and supporting documents.
(3) A review of product development processes and results.
(4) Product technical documents shall at least include:
1. The intended use of the product;
2. Product working principle / mechanism of action;
3. Main technical indicators and determination basis of the products, index requirements of main raw materials and key components, main production process and flow chart, and inspection methods of main technical indicators.
(5) Proof of product innovation should at least include:
1. Information or a new search report issued by a patent search agency;
2. Academic papers, monographs and document summaries published in the core journals that fully demonstrate the clinical application value of the products;
3. Analysis and comparison of the application of similar products listed at home and abroad (if any);
4. Product innovation and significant value in clinical applications.
(6) Product safety risk management report.
(7) Product manual (sample).
(8) Other evidence that the product complies with the second article of this procedure.
(9) An overseas applicant shall entrust an enterprise legal person in China as an agent or an office in China to submit an application and submit the following documents:
1. The power of attorney of an overseas applicant to entrust an agent or its office in China to apply for special approval for innovative medical devices;
2. The letter of commitment of the agent or the applicant's office in China;
3. The agent's business license or the institution's registration certificate for the applicant's office in China.
(10) Self-assurance statement on the authenticity of the submitted information.
The application materials should be in Chinese. If the original text is in a foreign language, there should be a Chinese translation.
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