For the record need to submit the following information: 1, the second class of medical devices business record form; 2, a copy of the business license; 3, the legal representative or person in charge of the enterprise, the person in charge of quality, the person in charge of the quality organization / full-time quality management personnel, maintenance, after-sales, technical and other personnel ID card, education, professional title (professional qualifications) certificates;
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4, business address, warehouse address plan (indicating the actual use of the area), the documents of property rights of the house or lease agreement (with documents of property rights of the house) a copy of the license; Class II medical devices 5, other proofs Materials (such as commissioned a copy of the storage and transportation contract, the door number of textual changes to prove that the medical device can be retailed instructions, etc.). Food and Drug Administration on the spot on the integrity of the information submitted by the enterprise to verify that meet the conditions to be filed, issued by the second class of medical equipment business record vouchers.
Two, according to the "supervision and management of the sale of medical devices network approach", engaged in the second class of medical devices network sales of enterprises, should obtain the second class of medical devices business filing vouchers.
From June 1, 2014, the operation of Class II medical devices do not need to apply for a license, but to the location of the local municipal Food and Drug Administration for the "Class II medical device business filing voucher".
Because it is to the municipal food and drug administration, the standards and materials may not be exactly the same in each place. The following is an example of Beijing:
1. "Class II Medical Device Business Record Form";
2. A copy of the business license and organization code certificate (check the original); the applicant holds a business license issued by the administrative department for industry and commerce loaded with a unified social credit code, without the need to submit the organization code certificate;
3. Legal representative, the person in charge of the enterprise, Quality of the person in charge of identification, education or title certificate; (check the original)
4. Organizational structure and departmental setup description;
5. Business premises, storage location map, floor plan (indicating the area), storage of property rights and proof of right to use a copy of the certificate; (commissioned storage, should be submitted to the commissioned party to sign a copy of a written agreement, the commissioned party's "Medical Device Business License" copy) (A copy of the "Medical Device License" and "other medical device manufacturers and operators to provide storage and distribution services for the record" copy)
6. Business facilities, equipment directory;
7. Business quality management system, working procedures and other documents directory;
8. Computer information management system basic information and functional description (if any);
9. Where the application for enterprise declaration materials, the specific processing personnel is not the legal representative or person in charge of himself, the enterprise should submit a "power of attorney";
10. Declaration of authenticity of the declaration material self-assurance statement, and the material to make a commitment to bear legal responsibility for any falsehoods.