2. review. After submitting the materials, the food and drug supervision and administration department will check the completeness of the materials submitted by the enterprise on the spot. If the application materials are complete and conform to the statutory form, the filing materials shall be accepted and the "Record Certificate for the Operation of Class II Medical Devices" shall be issued to the enterprise.
Legal basis: Regulations on the Supervision and Administration of Medical Devices
Twenty-ninth clinical trials are under way, and medical devices used to treat diseases that are seriously life-threatening and have no effective treatment methods can benefit patients after medical observation. After ethical review and informed consent, it can be used for other patients with the same condition free of charge in institutions that carry out clinical trials of medical devices, and its safety data can be used for medical device registration applications.
Thirtieth engaged in the second kind of medical devices business, business enterprises should be located in the districts of the municipal people's government food and drug supervision and management departments for the record, submit proof materials that meet the conditions stipulated in Article 29 of these regulations.
Article 31 An enterprise engaged in the operation of Class III medical devices shall apply to the food and drug supervision and administration department of the municipal people's government with districts where it is located, and submit certification materials that meet the conditions stipulated in Article 29 of these regulations.