Documents and Procedures Required for Establishment of Medical Equipment Enterprise and Permit

Documents needed by the medical equipment enterprise:

  • 1. Product Registration Certificate to produce.
  • 2. Production Permit, Business License, Organization Code Certificate and Tax Registration Certificate of the product manufacturer.
  • 3. Three full-time practitioners graduated from the majority of pharmacy or related, of which, there shall be one quality director with a college degree or above, who cannot hold the same post in other companies. Copies of identity cards of 3 persons, copies of academic certificates and resumes shall be provided. ( The originals of Identity Card and Academic Certificate shall be taken along when attending the interview with Drug Administration ).
  • 4. Name and several standby names of the company to be set up.
  • 5. A copy of the investor’s Identity Card with both sides ( The original is used at the time of capital verification ).
  • 6. Determined contribution proportion.
  • 7. Determined business scope.

Medical Equipment Business Permit:

  • 1. Enterprise name pre-approval;
  • 2. Provide relevant materials of the personnel and products ( the enterprise is responsible for it ), while decorate and lay out the offices and warehouses ( we are responsible for it );
  • 3. Documents are complete and the application is submitted on the website of State Drug Administration ( we are responsible for it );
  • 4. After the online application is approved, a full set of written materials shall be submitted to the State Drug Administration, which will review the written materials ( we are responsible for it );
  • 5. After the written application materials are approved by State Drug Administration, a notice of the time of checking and accepting sites shall be issued;
  • 6. Check and accepting sites ( all of the enterprise personnel shall be present );
  • 7. After the sites are checked and accepted, the permit will be examined and approved by the State Drug Administration;
  • 8. Obtain the Medical Equipment Enterprise Business Permit;
  • 9. Open an account and verify the capital contributions;
  • 10. Apply for three licenses ( Business License, Organization Code Certificate and Tax Registration Certificate ).

Note: After the enterprise submits complete materials and its sites are checked and accepted, the time of applying for Medical Equipment Enterprise Business Permit is about one month.

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