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.
Requirements for filing materials of Class II medical devices: 1, business license and copy; 2, the legal representative, the person in charge of the enterprise, the person in charge of the qualification certificate, education or professional title certificate; 3, professional and technical personnel list and professional and technical personnel's ID card, academic certificate, title certificate; 4. Organization and department setting; Description of business scope and mode of operation; 5. The geographical location map, floor plan, house title certificate or a copy of the house lease certificate of the business premises and warehouse address. If the warehousing entrusts the third party logistics of medical devices, an entrustment contract shall be provided; 6, management of quality management system, working procedures and other file directory. Including procurement, acceptance, warehousing, storage, quality tracking, user feedback, adverse event monitoring and quality accident reporting system and other documents; 7. Catalogue of operating facilities and equipment; 8, the enterprise has installed the computer information management system of the basic situation and function description, print the information management system home page.
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.