The shift from IVDD to IVDR represents a major change in how the IVD industry is regulated. While the EU Commission maintains that the system’s overall structure and approach remain consistent, manufacturers continue to face significant challenges.

To succeed in today’s medtech environment, companies must prioritize regulatory compliance and cybersecurity.

Medical device regulatory developments from the US and Thailand include: final FDA guidance on modular review for premarket approval applications and humanitarian device exemptions, and new expedited regulatory routes for low-risk devices and chronic disease prevention devices in Thailand.

This week, we are reporting on medical device regulatory updates from Canada, Europe, Brazil, and China. China's NMPA released registration review timelines, clarification on MDR and IVDR vigilance terms is now available, and Health Canada updated validation rules for non-eCTD transactions.

To kick off 2025, we bring you a round up of medical device regulatory updates from across Europe and the US, including a new position paper from TEAM-NB on MDR certification processes and numerous guidance updates from the US FDA.

Pure Global co-founder and COO DJ Fang is a technology executive and entrepreneur with over 15 years of experience driving digital transformation and innovation across industries, including finance, energy, and healthcare. He has led initiatives for Fortune 500 companies and government agencies, combining business expertise with technical skills in AI, cybersecurity, and cloud infrastructure.

The risks associated with inadequate supplier oversight are increasing as the industry becomes more global, with suppliers dispersed across multiple countries and subject to varying regulations. To maintain compliance on a global scale, manufacturers must implement a strategic and proactive supplier management process within their QMS to oversee supplier audits effectively.

Closing out 2024, we bring you substantial medical device updates from Europe, Brazil, and beyond, including the launch of public consultation on EU device regulations, an updated roadmap for regulatory implementations in the UK, and several new and updated resolutions in Brazil.

Early December 2024 regulatory news brings updates from Europe, US, Brazil, China, and Japan, including new FDA guidance on change controls for AI-enabled devices and an innovation-focused approach to clinical research regulations in Brazil.