View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
September 12, 2010

New Rules Will Force Chinese Medical Device Manufacturers to Report Faults

Medical equipment manufacturers in China will have to report any faults associated with their products, according to draft regulations issued by the Chinese Government. The new monitoring and recalls rules will require manufacturers to monitor the performance of medical equipment after p

By cms admin

Medical equipment manufacturers in China will have to report any faults associated with their products, according to draft regulations issued by the Chinese Government.

The new monitoring and recalls rules will require manufacturers to monitor the performance of medical equipment after purchase, and report any product-related faults or accidents to the State Food and Drug Administration (SFDA).

Manufacturers will be required to recall faulty products from the market and inform all businesses and customers concerned.

Hospitals and patients will also have a responsibility to inform the SFDA of any product faults.

The new rules would require implantable or life-sustaining devices to be registered with drug regulation authorities after clearing clinical trials.

China’s Legislative Affairs Office, part of its State Council, is asking for public submissions on the draft regulation on the supervision of medical devices.

Related Companies

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Get important industry news and analysis sent to your inbox
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU

Thank you for subscribing to Hospital Management