On June 24, 2025, the Global Harmonization Working Party (GHWP) officially stepped down as a member of the International Medical Device Regulators Forum (IMDRF). This decision marks a significant update for stakeholders in clinical, quality, and regulatory sectors connected to medical device harmonization efforts.
Effective as of the noted date, GHWP is no longer listed as a participating body of the IMDRF. Regulatory professionals and industry leaders should evaluate any impacts this withdrawal may have on existing policies or collaborations.
In this article:
What changed?
The GHWP, previously a contributing member of IMDRF, chose to voluntarily withdraw its membership as of June 24, 2025. This announcement is significant because the IMDRF plays a global role in advancing regulatory convergence and harmonization for medical devices. Moving forward, GHWP will no longer partake in IMDRF discussions, initiatives, or published guidelines.
While the specific reasons behind this decision remain undisclosed, GHWP’s leadership may pursue distinct agendas or independent collaborations regarding medical device regulatory frameworks in the future.
Who is affected?
Professionals across regulatory affairs, clinical operations, and quality assurance teams may encounter adjustments stemming from this change, particularly those relying on IMDRF outputs that previously integrated GHWP input. Regions heavily influenced by GHWP, including Asia and the Middle East, should monitor for any shifts in device approval criteria or regulatory standards.
Manufacturers engaged with GHWP-supported markets or partner organizations should remain vigilant about updates to guidance or protocol changes that could arise post-withdrawal.
Future implications for harmonization efforts
GHWP’s departure raises questions about broader harmonization among regional and international regulatory bodies. The move could lead to localized amendments in medical device requisites, potentially affecting global trade dynamics. Regulatory convergence, a key objective of IMDRF, may face slight hurdles in regions where GHWP was a key collaborator.
Stakeholders should proactively engage with emerging GHWP communications and strategies while tracking IMDRF’s new direction post-GHWP withdrawal.
Actionable steps:
- Assess regulatory strategies and dependencies involving GHWP guidelines.
- Stay updated on GHWP’s independent initiatives via direct communication channels.
- Monitor IMDRF publications for revised collaborations or membership additions.
FAQ
A: The International Medical Device Regulators Forum is a voluntary group of medical device regulators tasked with harmonizing regulations and promoting global alignment.
Q2: How does GHWP’s withdrawal impact industry?
A: GHWP’s absence from IMDRF may influence regulatory frameworks in regions it previously supported, requiring adjustments by stakeholders.
Q3: What should manufacturers focus on?
A: Manufacturers should focus on regional regulatory developments influenced by GHWP and maintain alignment with evolving IMDRF-related guidelines.
Conclusion
The Global Harmonization Working Party’s exit from IMDRF membership adds complexity to medical device regulatory dynamics, especially for regions historically impacted by GHWP contributions. Stakeholders are advised to closely monitor emerging communications from both organizations to optimize strategies and compliance practices.
Disclaimer
This material is intended solely for information purposes in regulatory and medical device contexts. It is not legal advice and should not replace consultation with qualified professionals.
Mandatory Announcement Details
For full information about the announcement, see the link below.