New 2019 standards for medical devices in China

China’s National Medical Products Administration (NMPA) in December began publicly soliciting opinions on proposed revisions to 94 medical device industry standards.

The revisions, part of a broad reworking of medical device industry standards in China over the past two years, are expected to have significant impact on the medtech industry, as Chinese authorities shift focus from pre-approval control to post-approval enforcement.

During the comment period, debate over the proposals are invited. The revision is expected to be enacted in 2019.