Your so-called quasi-production approval may refer to the Medical Device Manufacturing License (including production product registration form).
After October 1, 2014, the sequence of the above two documents is:
1, the first product registration: if the three types of medical devices to the State Food and Drug Administration for the "Medical Device Product Registration Certificate"; if the second type, to the provincial Food and Drug Administration for the "Medical Device Product Registration Certificate" .
2, after obtaining the registration certificate to the provincial Food and Drug Administration for the "Medical Device Manufacturing License", the specific production of products will be registered in the production of product registration form.
After obtaining the above two documents, you can produce normally.