What information is required to apply for a license to operate three types of medical devices

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 notification" 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.

Administrative licensing content

1, review and issue of new "Medical Device Business License" (second and third class of medical devices)

2, the second and third class of medical devices business enterprises to merge, separate or migrate across the original jurisdiction

Setting of the license of the legal basis

1, "Medical Devices Supervision and Administration Regulations";

2, "Medical Device Business License Management Measures"

Legal Responsibility

1, the applicant conceals the relevant information or provide false materials to apply for "Medical Device Business License", the provinces, autonomous regions, municipalities directly under the Central (food) Drug Administration or accept the entrusted municipal (food) drug supervision and management institutions on the Application is not admissible or not issued "medical device business license", and give a warning. The applicant shall not apply again within one year, "Medical Device Business License".

2, the applicant by deception, bribery and other improper means to obtain "medical device business license", (food) drug supervision and management department shall revoke its "medical device business 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