New medical devices for treating rare diseases and urgent public health needs will be subject to speedier evaluation and approval in China as part of a new set of medical device regulations published by the National Medical Products Administration (NMPA).
The regulations, which go into effect on June 1, allow conditional approvals for such devices in several cases, including a public health emergency. Some products whose safety and effectiveness have been proven in other countries will be permitted access to China’s markets without clinical evaluation. Making the devices exempt from the clinical trials previously required saves device manufacturers the expense of conducting the costly trials to win approval for the Chinese market.
In addition, patients with life-threatening diseases will be permitted access to devices still under clinical study if medical professionals deem the devices are of urgent benefit to the patients. And medical institutions will have greater latitude than in the past to use tests they develop in their own labs, as well as to directly import small quantities of Class 2 or 3 medical devices to meet urgent clinical needs.