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Author Topic: China encourages public reports of adverse outcomes from medical devices  (Read 545 times)
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« on: January 05, 2009, 01:19:48 AM »

The public and organizations should take part in reporting adverse outcomes from medical devices, the State Food and Drug Administration (SFDA) of China said in a new regulation.

The regulation, released on Wednesday, was developed by the SFDA and Ministry of Health.

Adverse outcomes are those in which approved devices function properly but lead to unexpected injuries or deaths.

People discovering events that have caused or might cause injury can report to provincial medical device monitoring centers or local drug administrations.

Manufacturers, distributors and users of medical apparatus mustreport deaths within five weekdays and events that might cause severe injuries or death within 15 weekdays.

China introduced a nationwide monitoring and re-evaluation system for adverse outcomes from medical devices in 2004. As of 2006, 31 provinces, autonomous regions and municipalities had set up provincial institutions to deal with reporting such events.

Based on reports, the SFDA revoked the registration certificates for polyacrylamide hydrogel, ordered the recall of extra corporeal circulation circuits and had dialysis powder re-registered.

Source: Xinhua
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