Conditions for handling the business license of medical devices:
1. It is required to have quality management personnel suitable for the business scale and business scope (quality management personnel should have relevant academic certificates recognized by the state).
2. It has an independent business place suitable for its business scale and scope.
3. Have suitable storage conditions, including storage equipment and equipment that meets the requirements of medical devices.
4. Have a complete management system (procurement, purchase, acceptance, warehousing, outbound audit, quality tracking and adverse event reporting system).
5 should have the technical training and after-sales ability to adapt to the medical device products.
6. To apply for a medical device business license, it must pass the acceptance of the Food and Drug Administration.
Materials for handling the business license of medical devices:
1. Application Form
2. Application Form for Pre-approval of Enterprise Name
3 enterprise quality management personnel's ID card, diploma or title copy and resume.
4. Organization and functions of enterprises
5. The geographical location map, floor plan and house property certificate of the registered address and warehouse of the enterprise.
6. Enterprise product management system
7. Business scope of the enterprise
Medical device business license handling process:
1. Submission
2. Material review
Check the address
Step 4 agree
This paper mainly introduces the materials and conditions of medical device business license required by Chinese enterprises to operate medical devices.