1, with the scope of business and business scale appropriate quality management institutions or quality management personnel, quality management personnel should have a nationally recognized relevant professional qualifications or titles; (Requirements: must be a medical device professional college) (Requirements: must be a medical device professional college degree or above 3 years of experience, more than 2 people);
2, with the scope of operation and business scale of the operation, storage space; (Requirements: the business site area needs to be consistent with the business products and business practices and laws and regulations);
3, with the scope of operation and business scale of the storage conditions, all entrusted to the storage of other medical device business enterprises can be Not set up a warehouse; (Requirements: business facilities and equipment need to be consistent with the operating products and business practices and laws and regulations);
4, with the operation of medical devices appropriate quality management system; (Requirements: business management system needs to be consistent with the mode of operation and business products and laws and regulations);
5, with the operation of medical devices appropriate professional guidance, technical training And after-sales service capacity.
Requirements for application materials:
1, business enterprises to submit the "Medical Device License Application Form" should be signed by the legal representative or stamped with the official seal of the enterprise;
2, "Medical Device License Application Form" should be filled out the items should be filled out completely and accurately;
3, The legal representative's identity certificate, academic title certificate and appointment document shall be valid;
4. The copy of "Notice of Pre-approval of Enterprise Name" or "Industrial and Commercial Business License" issued by the administrative department for industry and commerce shall be the same as the original one, and the copy is confirmed to be retained and the original one is returned;
5. The real estate certificate and the certificate of lease of the house (the lessor shall provide the certificate of property right) shall be valid;
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6, the person in charge of the enterprise, quality management 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, 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 directory of application materials in a bound volume.