Evolving Regulatory Landscape in APAC Points to Regional Medtech Growth

The past two months have seen the Chinese government issue many updates for the medical technology industry, in both summaries of technical guidance and China-unique standards; and in changes to the medical device review process.

These high-level updates include the National Medical Products Administration's (NMPA, formerly the CFDA) release of four registration technical review guidelines; and 27 new industry standards for medical devices, listed in this NMPA link (all links in Chinese). Three of the guidelines are here, and the fourth is here. The NMPA has also released a notification on the 2019 revision program of medical device industry standards, including updates and new drafts.