If a medical device manufacturer finds a defect in the medical device and fails to recall or refuses to recall the medical device, it shall be ordered to recall the medical device and be fined three times the value of the medical device to be recalled; If serious consequences are caused, the registration certificate of the medical device product shall be revoked until the production license of the medical device is revoked. Under the following circumstances, a warning shall be given, a correction within a time limit shall be ordered, and a fine of less than 30000 yuan shall be imposed:
Failing to inform the medical device business enterprise, user or user of the decision to recall the medical device within the specified time; Failing to take corrective measures or recall medical devices according to the requirements of the food and drug administration; Failing to make detailed records on the handling of the recalled medical devices or failing to report to the food and drug administration.
In case of the following circumstances, a warning shall be given and a correction within a time limit shall be ordered. If no correction is made within the time limit, a fine of less than 30000 yuan shall be imposed:
Failing to establish a medical device recall system in accordance with the provisions; Refusing to assist the food and Drug Administration in the investigation; Failing to submit report form of medical device recall, investigation and evaluation report and recall plan, implementation and summary report of medical device recall plan as required; The change of recall plan has not been reported to the food and Drug Administration for record.
Post time: Dec-10-2021