Medical organizations will have to report faults with medical equipment under new monitoring and recall rules proposed in a draft regulation issued by China's government Monday.

The Legislative Affairs Office of the State Council is seeking public submissions on the draft regulation on the supervision of medical devices.

The regulation would require medical equipment manufacturers to monitor the performance of their products once they were purchased.

Manufacturers and users, including hospitals and patients, would be obliged to report any accidents or faults to the State Food and Drug Administration (SFDA) or one of its local branches.

Equipment makers would be required to recall equipment that was substandard or failed to meet national technical standards and inform all concerned businesses and customers.

The draft says SFDA would be allowed to ensure they fulfilled their obligations, but it gave no details of the SFDA's powers in this respect.

Equipment that would be implanted into patients or used to sustain life must be registered with drug regulation authorities after passing clinical tests.

Commercials for medical equipment would need approval by local drug regulators.

The draft regulation defines medical equipment as instruments and devices for the purpose of diagnosis, treatment and disease prevention, as well as medical software.

The draft regulation is available online, and the public can make submissions until Sept. 24.

Go to Forum >>0 Comments