Engaged in the second, the third class of medical devices retail business enterprises should develop what regulations

Hello, engaged in the second, three types of medical equipment retail business enterprises should meet the requirements of the business sector in addition to apply for a medical device license. 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 examination and approval, and issued the "medical equipment business enterprise license". Medical device business license is now a post approval, business administration department issued a business license to apply for approval. The Medical Device Business License is valid for 5 years.

Applicants submit materials directory

Data No. 1, "Medical Device Business License Application Form", "Medical Device Business License.

Data No. 2, "Notice of Pre-approval of Enterprise Name" or "Industrial and Commercial Business License" issued by the Administration for Industry and Commerce.

Data No. 3, Application Report.

Data No. 4, supporting documents for business premises and warehouse premises, including copies of property certificates or lease agreements and property certificates of the lessor.

Data No. 5, business premises, warehouse layout plan.

Data No. 6, the proposed approach to determine the person in charge, the person in charge of the enterprise, the quality manager's identity card, a copy of the certificate of academic qualifications or title certificate and personal resume.

Data No. 7, a list of technical staff and copies of academic and professional title certificates.

Data No. 8, business quality management standardized document catalog.

Data No. 9, the enterprise has been installed in the product purchase, sale, inventory information management system, print information management system home page.

Data No. 10, storage facilities and equipment catalog.

Data No. 11, quality management personnel on duty self-assurance statement and self-assurance statement of the authenticity of the application materials, including the directory of application materials and the enterprise to the material to make a commitment to bear legal responsibility if false;

Data No. 12, where the application for the enterprise to declare the material, the processing staff is not the legal representative or person in charge of the person himself, the enterprise should submit the "letter of authorization .

Data No. 13, apply for a "medical device business license" confirmation

Requirements for the application materials

1, business enterprises should be submitted to 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" the fill in the project should be filled out Complete and accurate, fill in the content should meet the following requirements.

A, "business name", "registered address" and "industrial and commercial business license" or "pre-approved notice of enterprise name" is the same.

B, to apply for the business scope of the State Drug Administration in 2002 issued by the "Classification of Medical Devices Catalog" a directory to fill out.

C, "registered address", "warehouse address" should be filled out specific door, floor and room number.

3, the legal representative's identification, proof of academic title, appointment documents should be valid;

4, industrial and commercial administration issued by the "pre-approval of enterprise name notification" or "business license" copy should be the same as the original, the copy to confirm the retention of 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 of the person in charge of the 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, then the legal representative must be signed or signed in person.

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, photocopy on A4 paper, according to the order of the catalog of application materials in a bound volume.