Two, the "medical device business license" is a must-have certificate for medical device business enterprises. The establishment of second-class medical device business enterprises shall be filed with the pharmaceutical supervisory and administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the central government;
The establishment of Class III medical device trading enterprises shall be examined and approved by the pharmaceutical supervisory and administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government, and a License for Medical Device Trading Enterprises shall be issued. The medical device business license is now post-approved, and the administrative department for industry and commerce will apply for approval after issuing the business license. The validity period of the Medical Device Business Enterprise License is 5 years.
3. Procedures for handling individual business licenses;
1, my ID card and photocopy (foreigners need temporary residence permit and photocopy).
2, the premises of the housing lease contract or real estate license and a copy.
3. Two one-inch bareheaded color photos.
4. If they are laid-off workers and poor households of state-owned and collective enterprises. You also need to bring unemployment cards, preferential cards for unemployed people, special hardship cards and their copies in order to enjoy preferential policies for reducing or exempting management fees in accordance with relevant state regulations.
5, engaged in food, cosmetics and other special industries, but also need to prepare health certificates and copies (involving pre-approval industries need to provide approval opinions).
Bring the above documents to the local industrial and commercial office and explain to the staff what kind of business license to apply for. After checking the relevant documents, the staff will fill in the form.
Extended data
List of materials to be submitted for medical device business license
Data number 1, medical device business license application form, medical device business license.
2. Notice of pre-approval of enterprise name or business license issued by the administrative department for industry and commerce.
No.3, application report.
4. Proof documents of the business premises and storage premises, including the copy of the title certificate or lease agreement and the title certificate of the lessor.
Data 5. Layout of business premises and warehouses.
Copy of ID card, graduation certificate or professional title certificate and resume of the person in charge of the proposed method, the person in charge of the enterprise and the quality manager in Document 6.
7. List of technical personnel and copies of academic qualifications and professional title certificates.
Data No.8. Directory of Management Quality Management Specification Documents.
9. The product invoicing information management system installed by the enterprise, and the homepage of the information management system is printed.
Material number 10, storage facilities and equipment catalogue.
Data number 1 1, on-the-job self-assurance statement of quality management personnel and self-assurance statement of authenticity of application materials, including the catalogue of application materials and the enterprise's commitment to bear legal responsibility for any falsehood;
The material number is 12. If the handler of enterprise application materials is not the legal representative or the person in charge himself, the enterprise shall submit a power of attorney.
MaterialNo. 13, Application for Medical Device Business License Confirmation