1. Class II medical device business filing form; (the filing form needs to be signed by the legal person)
2. A copy of the business license; (Note: the business scope of the business to have "Class II medical device business")
3. Legal representative of the enterprise, the person in charge of the enterprise, the person in charge of quality ID card (required), a copy of the certificate of education or title certificate (choose one).
4. organizational structure and departmental setup description; (departmental setup description is to explain the main responsibilities of each position)
5. business premises, warehouse address location map, floor plan (drawings written on the actual use of the area), a copy of the lease contract and proof of ownership of the house documents (business premises, warehouse address proof of ownership of the house: real estate license, proof of record, proof of use of the site) One of the three can be)
6. business facilities and equipment directory; (refers to the business premises and warehouse facilities and equipment)
7. business quality management system directory
8. work program directory;
9. original power of attorney and a copy of the agent's identity card; (the power of attorney needs to be signed by the legal person)
10. record material Authenticity of the self-assurance statement (legal person needs to sign)
11. Treasury address is entrusted to a third-party company storage, distribution, you need to submit a copy of the third-party company's two types of filing certificates, a copy of the business license, and a copy of the agreement signed by both parties to the contract. (Not entrusted to a third-party company storage, distribution is not required to provide)
12. Declaration of material directory
What is required for the filing of Class II medical devices
1, business license and a copy of the business license;
2, legal representative, responsible person for the enterprise, the person in charge of quality of the identity of the person in charge of the certificate, certificate of academic qualifications or titles;
3, professional and technical personnel list and professional and technical personnel. List of professional and technical personnel and professional and technical personnel of the identity card, proof of education, title certificate;
4, organizational structure and departmental setup; business scope, business mode description;
5, business premises, warehouse address of the geographic location of the map, floor plan, documents proving ownership of the house or by the housing rental issued by the housing lease certificate copy of the lease. Warehousing commissioned by the third-party logistics of medical devices, provide the commissioning contract;
6, business quality management system, work procedures and other documents directory. Including procurement, acceptance, warehousing, warehousing, quality tracking, user feedback, adverse event monitoring and quality incident reporting system and other documents;
7, business facilities, equipment catalog;
8, the enterprise has been installed in the computer information management system basic information and functional description, print the information management system home page.
"The People's Republic of China *** and the Basic Medical Care and Health Promotion Law"
Article 65 of the State to strengthen the management of medical devices, improve the standards and norms of medical devices, and improve the safety and effectiveness of medical devices. The competent health department of the State Council and the competent health department of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall, in accordance with the advanced nature, appropriateness and accessibility of the technology, prepare a plan for the allocation of large-scale medical equipment, and promote the rational allocation and full *** enjoyment of medical equipment in the region.