What is the classification of medical device recall?

Medical device recall is mainly classified according to the severity of medical device defects

First class recall, the use of the medical device may or has caused serious health hazards.

Secondary recall, the use of the medical device may or has caused temporary or reversible health hazards.

Three level recall, the use of the medical device is less likely to cause harm, but still need to be recalled.

Medical device manufacturers shall scientifically design and organize the implementation of recall plans according to the recall classification and the sales and use of medical devices.


Post time: Dec-10-2021