Class II medical device business filing what information is needed

According to the "supervision and management of medical equipment business approach" and "Fushun City, medical equipment business quality management standard on-site inspection and evaluation standards" requirements. Fushun City, Fushun City, the jurisdiction of the enterprise, "Class II medical device business record", should meet the filing conditions, and provide relevant information in line with the provisions.

Basic conditions:

1. Should have the qualification of the enterprise "business license.

2. Enterprises should set up full-time quality management personnel.

Operation of in vitro diagnostic reagents should have a supervisor inspector or a person with a college degree or above in testing related disciplines.

The person in charge of quality (college education) and technical personnel (intermediate or higher professional and technical titles) of the education should have the relevant professional: medical devices, biomedical engineering, machinery, electronics, medicine, bioengineering, chemistry, pharmacy, nursing, rehabilitation, laboratory science, computers, law, management and so on.

3. Business premises: the second category of wholesale enterprises shall not be less than 50 square meters of business premises.

The second category of retail enterprises shall not be less than 20 square meters of business premises.

The second type of wholesale and retail enterprises shall not be less than 70 square meters of business premises.

4. Treasury: the second category of wholesale, wholesale and retail enterprises shall not be less than 20 square meters of storage space.

Business premises and warehouses shall not be located in residential housing.

The second category of retail enterprises can not set up storage.

The wholesale of in vitro diagnostic reagents should be set up not less than 20 cubic meters of cold storage.

Data directory:

1, medical device license application form

2, "Business License" copy;

3, the legal representative, the person in charge of the enterprise, the person in charge of quality of the identification, education or title certificate

Ming copy;

4, organizational structure and departmental setup description;

5, the scope of business, the business mode of description;

6, Business premises, warehouse address location map, floor plan, documents proving property rights or rental lease agreement (with documents proving property rights) copy; 7, business facilities, equipment directory; 8, business quality management system, work procedures and other documents directory; 9, computer information management system basic information and functional description; 10, Proof of authorization by the operator;

11, other supporting materials (including the following materials).

(1) certificate of registration of the product to be operated and accessories;

(2) information is done, uploaded one by one to the information system corresponding to the * item, no corresponding item of the unified upload to other materials.