In this episode, Medtech Insight senior reporter Hannah Daniel interviews DJ Fang, COO and co-founder of Pure Global. Pure Global employs AI to assist device manufacturers in navigating global regulations. Their discussion covers clinical trials, how countries incentivize medtech innovation, and the Biden Administration’s tariffs on certain Chinese-made medical devices.

NMPA fosters medical device innovation through regulatory consultations, tailored plans, guidance, updates on approvals, and compliance with MDR, IVDR, and MPDG.

COFEPRIS regulates the transfer of rights to ensure legal and technical compliance for medicines, medical devices, and biological products. Requirements include an application format, proof of payment, legal documentation, and a notice of operation. Transfers must be transparent, with continuous monitoring. Modifications now resolve within 24 hours instead of 3 months.

The Clinical Trials Coordination Group (CTCG) published a Q&A for clinical trial sponsors on safety reporting. Highlights include active RFI monitoring, immutable annual reports, and CTIS transition guidelines.