Premier Li signs regulation on medical device supervision

Premier Li Keqiang has signed a revised regulation on the management and supervision of medical devices in order to standardize the use of large medical equipment and ensure safety.

The revision is aimed at promoting the reasonable allocation of medical resources and preventing medical institutions from abusing equipment to increase their earnings.

According to the regulation, the list of large medical devices will be approved by the State Council and health authorities will supervise and evaluate the use of these devices.

Medical institutions should obtain approval from health authorities at the provincial level and above before installing large medical equipment, it said.

Institutions that install large medical equipment should have the required technical conditions, the ability to use the devices, ancillary facilities and qualified technicians.

There should be Chinese instructions and tags on imported medical facilities, while enterprises exporting medical devices should make sure they meet the requirements of the destination countries, it said.

The regulation takes immediate effect upon publication.