1. Operation Record Form of Class II Medical Devices; (The filing form needs the legal person's autograph)
2. A copy of the business license; (Note: The business scope of industry and commerce should include "the second kind of medical device business")
3. The ID card of the legal representative of the enterprise, the person in charge of the enterprise, and the person in charge of quality (required), and a copy of the academic certificate or professional title certificate (choose one from two).
4. Description of organizational structure and department setting; (The description of department setting is to explain the main responsibilities of each position)
5. The geographical location map and floor plan of the business premises and warehouse address (the actual use area is written on the drawings), a copy of the lease contract, and the property right certificate of the house (the property right certificate of the business premises and warehouse address: only one of the property right certificate, the filing certificate and the site use certificate).
6. Catalogue of business facilities and equipment; (refers to the facilities and equipment of business premises and warehouses)
7. Management quality management system directory
8. Catalogue of working procedures;
9. The original power of attorney and a copy of the agent's ID card; (The power of attorney requires the legal person's autograph)
10. Self-assurance statement on the authenticity of filing materials (signed by legal person)
1 1. If the warehouse address is entrusted to a third-party company for storage and distribution, a copy of the second-class filing certificate of the third-party company, a copy of the business license and a copy of the agreement and contract signed by both parties shall be provided. (Not required unless a third-party company is entrusted to store and distribute)
12. Catalogue of application materials
What do I need for the filing 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.
People's Republic of China (PRC) Basic Medical Care and Health Promotion Law
Article 65 The State strengthens the management of medical devices, improves the standards and specifications of medical devices, and improves the safety and effectiveness of medical devices. The health authorities of the State Council and the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall, according to the advanced nature, suitability and accessibility of technology, formulate plans for the allocation of large-scale medical equipment, so as to promote the rational allocation and full enjoyment of medical equipment in this region.