1. The Application Form for Medical Device Business License submitted by the business enterprise shall be signed by the legal representative or stamped with the official seal of the enterprise;

2, "medical device business license application form" to fill in the project should be complete and accurate;

3. The identity certificate, education certificate, professional title and appointment document of the legal representative shall be valid;

4, issued by the administrative department for Industry and commerce "enterprise name pre-approval notice" or "business license" copy should be the same as the original, copy confirmed retained, the original returned;

5. Property right certificate and house lease certificate (the lessor shall provide the property right certificate) shall be valid;

6, the person in charge of the enterprise, the quality manager's resume, diploma or title certificate should be within the validity period;

7, enterprises should establish medical device quality management documents or forms according to their own reality.

8. The self-assurance statement of the authenticity of the application materials shall be signed by the legal representative and stamped with the official seal of the enterprise. If there is no official seal, it shall be signed or sealed by the legal representative himself.

9. If the application materials need to be copied, the applicant (unit) shall indicate the words "this copy is consistent with the original" or a written explanation on the copy, indicate the date and affix the official seal of the unit; Individual applications should be signed or sealed.

10. The application materials shall be complete, clear, signed and stamped with official seals one by one. All application forms should be typed and filled in by computer, printed on A4 paper, copied on A4 paper, and bound in the order of application materials.

Extended data

Legal liability:

If the applicant conceals relevant information or provides false materials, the (food) drug supervision and administration department of a province, autonomous region or municipality directly under the Central Government or the (food) drug supervision and administration institution of a city divided into districts shall not accept the application or issue a Medical Device Business License and give it a warning. The applicant shall not apply for the Medical Device Business License again within 1 year.

If the applicant obtains the medical device business license by cheating, bribery or other improper means, the (food) drug supervision and administration department shall revoke its medical device business license, give a warning and impose a fine of 6,543,800 yuan to 20,000 yuan. The applicant shall not apply for a medical device business license again within 3 years.

Baidu Encyclopedia-Medical Device Business License