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医疗器械召回管理办法(4-6)-EN

Chapter IV Mandatory Recall

Article 24. Where, through investigation and evaluation, the food and drug regulatory authority deems that the medical device manufacturer shall recall the defective medical device but the manufacturer fails to do so voluntarily, the food and drug regulatory authority shall mandate it to recall the medical device.

The decision of mandatory recall can be made by the food and drug regulatory authority of the province, autonomous region or municipality directly under the Central Government where the medical device manufacturer is located, or by the food and drug regulatory authority that has approved the medical device registration or performed the filing. The food and drug regulatory authority that has made the decision shall publicize the mandatory recall information on its website.


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