Manufacturers of Medical equipment in China will have to report fault in their products


Healthcare News/ Medical Equipment & Devices :- 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.