Medical device license how to do, what qualifications are needed

Medical equipment business license is a medical device business enterprises must have the documents, the opening of the second class of medical equipment business enterprises, should be to the provinces, autonomous regions and municipalities directly under the Central People's Government drug supervision and management department for the record; the opening of the third class of medical equipment business enterprises, should be by the provinces, autonomous regions and municipalities directly under the Central People's Government drug supervision and management department for review and approval, and issued the "Medical Device Business License". Medical device business license is now a post approval, the business administration department issued a business license to apply for approval. The Medical Device Business License is valid for 5 years.

1 business enterprises to submit the "Medical Device Business License Application Form" should be signed by the legal representative or stamped with the official seal of the enterprise;

2 "Medical Device Business License Application Form" should be filled out the items should be filled out completely and accurately;

3 legal representative of the identity card, proof of academic title, appointment of documents should be valid;

4 Administration for Industry and Commerce issued a "notice of pre-approval of enterprise name" or "industrial and commercial business license" copy should be the same as the original, a copy of the confirmation of retention, the original is returned;

5 Proof of real estate, proof of rental of housing (the lessor to provide proof of property rights) should be valid;

6 Resume of the person in charge of the enterprise, the quality of the person responsible for quality management, proof of academic qualifications or title should be valid;

7 The enterprise shall be valid;

7 enterprises should be based on their own actual establishment of medical device quality management files or forms.

8 Self-assurance statement of the authenticity of the application materials should be signed by the legal representative and stamped with the official seal of the enterprise, or if there is no official seal, the legal representative must be signed or signed.

9 Where the application materials need to submit a copy, the applicant (unit) must be indicated on the copy of the words "this copy and the original" or text description, date, stamped with the official seal of the unit; personal application must be signed or sealed.

10 application materials should be complete, clear, signed, and stamped copy by copy, all application forms computer typing to fill out, print on A4 paper, photocopying A4 paper, according to the order of the catalog of application materials in a bound volume.

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