Must the quality system for medical product registration operate for more than 3 months?

Yes. The products covered by the quality system should comply with the relevant national standards or industry standards, the applicant should establish a documented management system, and formally run in accordance with the standards of the application for certification. Production of three types of medical devices, the quality management system shall not run less than 6 months, the production of other products shall not be less than 3 months, should be at least one internal audit and a management review.