Requirements for the application materials:
1, operating 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 in the items should be filled in completely and accurately;
3, proof of identity of legal representatives, proof of academic title, Appointment documents should be valid;
4, industrial and commercial administration department issued a "pre-approval of enterprise name notice" or "business license" copy should be the same as the original, the copy confirmed to be retained, the original is returned;
5, real estate certificates, proof of rental of premises (the lessor to provide proof of property rights) should be valid;
6, the person in charge of the enterprise, the quality manager Resume, proof of education or title should be valid;
7, the enterprise should be based on their own actual establishment of medical device quality management files or forms.
8, the 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 stamped.
9, where the application materials need to submit a copy, the applicant (unit) shall indicate on the copy of the words "this copy is consistent with the original" or text description, date, and stamped with the official seal of the unit; personal application shall be signed or stamped.
10, the 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 on A4 paper, according to the order of the catalog of application materials in a bound volume.
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Expanded Information
Legal Responsibility:
If the applicant conceals the relevant information or provides false materials, the provincial, autonomous regions, municipalities directly under the Central (food) drug supervision and management department or accept the entrusted municipal (food) drug supervision and management agency shall not accept the application or shall not issue the "medical device business enterprise license", and give a warning. The applicant shall not apply again within one year, "Medical Device Business License".
If the applicant obtains the Medical Device Operator License by cheating, bribery and other improper means, the (food) drug regulatory authorities shall revoke the Medical Device Operator License, give a warning, and impose a fine of 10,000 yuan or more than 20,000 yuan. The applicant shall not apply again for a "medical device business enterprise license" within three years.
/www.baidu.com/link?url=Aze58NKza10zGB8edP_ LS7wmx2bDtituOsYu7bQbqlwBuE2HDsJZ9MFxkslQupfzpxiH6CJ8dt7fdfw00CysbQBQjgudQJctWcLgj8Q0svY8RSQfBGTPpCF778sNvypb1cjAczvbqr4WDFU7qO51kyGXz3WNBHuEgJSiW98oJGJpD8AT71xLG _mDZOyAKUF-&wd=&eqid=ca43319b001e993e000000035cebdda6 "target="_blank "title="Support only works when a link is selected">Baidu Encyclopedia- -Medical Device License