Requirements for the application materials:
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 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 a description of the words, indicate the 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, photocopies on A4 paper, according to the order of the catalog of application materials in a bound volume.
Extended Information
Legal Responsibility:
Applicants conceal the relevant information or provide false materials, the provinces, autonomous regions, municipalities directly under the Central (food) Drug Administration or accept the entrusted municipal (food) drug supervision and management agencies of the application will not be admissible or will not be issued, "Medical Devices Business Enterprise License", and give a warning. The applicant shall not apply for another "medical device business license" within one year.
If the applicant obtains the Medical Device Operator's License by cheating, bribery or other improper means, the (food) drug regulatory authority shall revoke the Medical Device Operator's 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 the "Medical Device Business Enterprise License" within 3 years.
Baidu Encyclopedia - Medical Device Business License