BEIJING — China will strengthen supervision on the safe use of medical devices in accordance with recently issued measures that come into force next year, said the country’s drug watchdog.
Wang Shucai, deputy head of the Department of Medical Device Supervision with the China Food and Drug Administration (CFDA), said illegal purchases of medical instruments and lack of maintenance have seriously impaired the quality of treatment and patients’ health.
Therefore, the CFDA has, for the first time, formulated a series of measures for supervision and administration of the use of medical devices in October, which will take effect on Feb 2, 2016, according to Wang.
Wang said food and drug administrations will monitor equipment use in hospitals and launch inspections on medical device manufacturing enterprises as well as agencies providing maintenance and repair services.
Special attention will be given to high-risk medical instruments, added Wang.
To ensure the safe use of medical devices, the new regulation stipulates that hospitals should establish records of maintenance. It also specifies management responsibilities in regulating the purchase, checking, storage, transfer and donation of medical devices.