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.

Recent global regulatory updates include changes for software-based medical devices, prescription lenses, and microbial, recombinant, or animal substances. Effective June 15 and July 1, 2024, with reclassification by July 1, 2026. High-risk devices have limited audits; spectacle lenses are ARTG exempt from June 15.

The two companies are enhancing their ability to navigate regulatory landscapes and effectively facilitate market access.

As regulatory requirements get more complex, the need for speed within the regulatory function becomes increasingly important. Amid these changes, a fundamental question arises: do compliance and regulation have to be so challenging?

In the dynamic landscape of medical device and in vitro diagnostic (IVD) manufacturing, balancing the critical elements of time, resources and regulatory compliance is crucial, reports Phyllis Meng, cofounder and CEO of Pure Global.

In May 2024, major regulatory updates were announced across the UK, EU and Switzerland to enhance medical and in vitro diagnostic devices. The COMBINE project was launched to streamline regulations, and new standards and frameworks were proposed to improve safety, compliance, and timely access to innovative treatments.

Pure Global, a provider of global market access services, and MEDIcept, a consultancy offering U.S. and EU regulatory, quality, and clinical services, are joining forces to support regulatory compliance and speed market access for medical device and in vitro diagnostics (IVD) providers.