Notice of Shanghai Food and Drug Administration on Strengthening Supervision and Management of Medical Device Businesses
Market supervision & management bureaus of each district:
In recent years, as the laws on the supervision of medical devices have been revised and improved gradually, and the regulation has also been strengthened, the medical device businesses in Shanghai have also constantly improved their legal consciousness. But our administration has found in daily supervision, reported complaints, case investigation and relevant survey that some medical device businesses still lack effective quality management and some businesses even have violation acts. In order to strengthen the supervision of business operation of medical devices in Shanghai, relevant measures are hereby notified as follows:
I. Further strengthening whole-process supervision of medical device businesses
The principle that “those granting approvals shall be held accountable” shall be adopted. The market supervision bureaus of each district shall intensify regulation during and after the event while tightening the permitted access of medical device businesses, so that each administrative district will perform their due responsibilities. At the same time, laws and regulations shall be publicized and promoted among local medical device businesses, to strengthen their legal awareness and urge them to fulfill their responsibilities as business entities. As for the business operators whose operation site and storage site are set in different administrative districts, daily regulation shall be strengthened, to carefully verify the practical operation, storage and delivery of these businesses. The enterprises that initiatively deregister the business qualification shall be verified to check whether they are under investigation, whether the investigation is still underway, and the progress of product disposal, to prevent safety risks. Enterprises shall be investigated and punished strictly if they change their operation sites and storages without authorization, and engage in operations that are not in compliance with laws or with the operation and quality management standards for medical devices.