When a medical device business enterprise finds out what medical devices it is dealing in, it shall immediately stop operating and notify the medical device registration.

1) If the (incoming goods) are unqualified, the unqualified items shall be marked, put into the nonconforming product area, and measures such as return and destruction shall be taken according to relevant regulations.

(two) prohibit the sale of expired medical devices, take disposal measures such as destruction in accordance with relevant regulations, and keep relevant records and original materials.

(3) If an enterprise finds that the medical devices it operates have serious quality and safety problems, or do not meet the technical requirements of registered or filed medical devices, it shall immediately stop operating, notify relevant production and operation enterprises, users and purchasers, and record the situation of stopping operating and notifying. At the same time, immediately report to the food and drug supervision and administration department where the enterprise is located.

What should medical device enterprises do after discovering adverse medical device events?