Moving forward with efforts to expand the options for testing of medical devices offered for sale in China, the government is soliciting opinions on a proposal to permit the testing of medical devices in testing centers not certified by the National Medical Products Administration.
The May 7 announcement is welcome news for medical device manufacturers, who have been required to test their products in a narrow range of Chinese centers to date. But the eased regulation is still subject to the results of the public comment period and to the institution of requirements to ensure the quality, management, certification, and supervision of third-party testing sites.