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医疗器械召回管理办法(1-3)-EN

Decree of China Food and Drug Administration

No. 29


The Provisions for Medical Device Recall, adopted at the executive meeting of China Food and Drug Administration on January 5, 2017, is hereby published and shall be effective as of May 1, 2017.


Minister: Bi Jingquan

January 25, 2017


Provisions for Medical Device Recall


Chapter I General Provisions


Article 1. To strengthen the supervision and administration of medical devices, control defective medical device products, eliminate potentially hazardous medical devices, ensure the safety and effectiveness of medical device, and guarantee human health and safety, according to Regulations for the Supervision and Administration of Medical Device, the CFDA has formulated these Provisions.

Article 2. The Provisions applies to the recall and recall supervision and administration of medical devices marketed in the territory of the People’s Republic of China.

Article 3. ‘Recall’ as defined in the Provisions refers to the activity that, medical device manufacturers, according to stipulated procedures, eliminate the marketed medical device products of a certain type, model or batch which have defects, through alerting, checking, fixing, relabeling, revising and improving instructions for use (IFU), upgrading software, replacing, recalling, destroying and other means. 


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