Filing requirements:
1. Enterprises, enterprise legal representative or responsible person for the enterprise, the person in charge of quality management without "supervision and management of medical devices regulations" Article 63, Article 65 of the circumstances;
Article 63 One of the following circumstances, by the people's government at or above the county level Food and drug supervision and management department shall confiscate the illegal income, illegal production and operation of medical devices and tools, equipment, raw materials and other items used in the illegal production and operation; illegal production and operation of medical devices less than 10,000 yuan in value and impose a fine of 50,000 yuan to 100,000 yuan; value of 10,000 yuan or more and impose a fine of 10 times the amount of 10 times the amount of 20 times the amount of the fine; if the circumstances are serious, within five years not to Accept the relevant responsible persons and enterprises to apply for a medical device license:
(a) the production and operation of medical devices without obtaining the certificate of registration of medical devices of the second class, the third class of medical devices;
(b) engaged in the production of the second class, the third class of medical devices without authorization;
(c) engaged in the operation of the third class of medical devices without authorization.
The first paragraph of the preceding circumstances, the circumstances are serious, by the original licensing department to revoke the medical device manufacturing license or medical device license.
Article 65 is not filed in accordance with the provisions of these regulations, by the people's government at or above the county level food and drug supervision and management department shall order a period of time to make corrections; failing to do so, the public announcement of the failure to file the name of the unit and the product, and may impose a fine of less than 10,000 yuan.
For the record to provide false information, by the people's government at or above the county level, food and drug supervision and management department of the public announcement of the filing of the unit and the name of the product; the circumstances are serious, the person directly responsible for the five years shall not be engaged in the production and operation of medical equipment activities.
2. with the scale and scope of operation and business premises and storage conditions;
3. with the operation of medical devices and quality management system and quality management organizations or personnel.
List of materials to be submitted (1 copy each according to the following directory):
1. Class II medical device business filing form;
2. A copy of the business license of the enterprise;
3. The legal representative or person in charge of the enterprise, the person in charge of quality of the identity of the person in charge of the enterprise, academic qualifications, professional titles, and certificates of the relevant personnel (wholesale companies: the person in charge of the enterprise, the warehouse manager, the purchasing and sales staff and quality administrator; stores: quality control system and personnel) and quality manager; stores: quality manager) of the training certificate;
4. Description of the organization and departmental setup;
5. Business premises, warehouse address location map, floor plan (indicating the actual area of use), documents proving ownership of the house or lease agreement (with documents proving ownership of the house) a copy;
6. Business facilities and equipment catalog;
7. business quality management system, work procedures and other documents catalog;
8. medical device business enterprises (wholesale, retail) self-inspection form;
9. medical device business enterprise quality and safety commitment;
10. medical device business enterprise safety commitment;
11. the operator Authorization letter;
12. Self-assurance statement of the authenticity of the filing materials;
13. Electronic version of the filing materials.
Submission requirements:
1. The record materials should be complete, clear, printed and bound on A4 paper with a table of contents, a copy of the official seal and submit with the electronic version.
2. Changes in the name of the enterprise, the legal representative, the person in charge of the enterprise, the person in charge of quality, the scope of business, business address, depot address and other filing matters. (1) such as changes in business name, legal representative of the enterprise, the person in charge of the enterprise, should be submitted: the legal representative, the person in charge of the enterprise's identity card, proof of education or title certificate; has changed the "industrial and commercial business license" copy; (2) such as changes in the business address of the enterprise, you need to provide the business premises floor plan, documents proving ownership of the house or lease agreement (with documents proving ownership of the house), location map. (3) such as changing the scope of business, change the address of the warehouse, you need to provide the warehouse floor plan, documents proving property rights or lease agreement (with documents proving property rights), geographic location map, warehouse facilities and equipment catalog. (4) such as changes in quality management, need to provide the proposed quality management education, title certificate, ID card copy.
3. Such as the operation of in vitro diagnostic reagents, the quality manager is required to have the title of competent examiner as a person, and need to provide relevant cold chain facilities to prove the material. Such as standby generator sets or standby refrigeration units, automatic temperature controllers, automatic alarm equipment, refrigerated trucks and other invoices, cold storage installation contracts, operating certificates of compliance. If you can not provide the above conditions, the scope of business is "6840 in vitro diagnostic reagents (except for products subject to cold chain management).
4. Business enterprises operating hearing aids, the need to provide the appropriate fitting facilities and equipment (such as hearing test room, fitting room, hearing test equipment or instruments, etc.) and primary hearing test professional qualifications and other technical personnel.