ARTICLE SUMMARY:
In this week’s Pathways Picks: China NMPA publishes a draft medical device management law; FDA issues a trove of De Novo decision summaries including one describing a predetermined change control plan for a machine learning devices; regulatory updates from the EU, Spain, and Brazil; and dates to remember.
Top Pick
More change coming in China:
A new view on legal agents. The National Medical Products Administration has published a new draft “management law” (link in Simplified Chinese) intended to underpin medical device regulation in China. Primarily, it seeks to reinforce China’s current regulatory framework, including an emphasis on postmarket surveillance requirements. It also incorporates some specific reforms to the framework, including stricter requirements on the types of entities that can act as legal agents that represent foreign companies marketing devices in China, according to Jocelyn Zhu, chief operating officer for China-based consulting firm TX Medical. The legal agent issue is likely to be a significant focus of comments submitted by industry to NMPA in response to the draft law, Zhu told Market Pathways. Comments are due September 28 and Zhu expects NMPA will consider updating the provisions before the measures are finalized. (Look out for more details on the draft China management law soon in Market Pathways.)
