On June 24, 2025, the Global Harmonization Working Party (GHWP) officially withdrew as a member of the International Medical Device Regulators Forum (IMDRF). This move marks a significant shift for regulatory professionals and industry stakeholders who rely on harmonized guidelines for medical device conformity.
The announcement is particularly important for clinical, quality, and regulatory teams who follow global medical device policies to ensure compliance. GHWP’s departure from IMDRF means potential changes in collaborative processes and frameworks related to international device regulations.
What changed?
The GHWP formally announced its voluntary withdrawal from IMDRF as of June 24, 2025. This decision effectively ends GHWP’s collaboration under IMDRF’s umbrella. No details were provided regarding the reasoning behind this decision in the announcement.
IMDRF, known for its leadership in promoting global regulatory alignment, has historically worked closely with GHWP to address shared challenges in medical device safety and performance.
Who is affected?
This decision impacts a broad spectrum of stakeholders in the medical device industry, including:
- Regulators who depend on alignment between global standards.
- Manufacturers navigating compliance in international markets.
- Clinical and quality teams involved in device testing and certification.
- Policy developers and consultants working in global harmonization.
Without GHWP’s involvement in IMDRF, these stakeholders may experience changes in the alignment of guidance documents, international policies, and collaborative harmonization efforts.
Implications for regulatory processes
The withdrawal of GHWP could lead to shifts in how medical device regulations and guidelines are developed and implemented across member jurisdictions. Some of the potential implications include:
- Disrupted harmonization efforts for international medical device regulations.
- Challenges in maintaining streamlined conformity processes across countries.
- Potential bottlenecks in collaborative studies or development initiatives.
For organizations operating globally, efforts will need to focus on understanding new or divergent regulatory systems moving forward.
FAQ
Q1. What is IMDRF?
IMDRF stands for the International Medical Device Regulators Forum, a group promoting global alignment of medical device regulatory standards.
Q2. What does GHWP do?
GHWP (Global Harmonization Working Party) focuses on medical device regulatory harmonization and guidance across global markets.
Q3. Why did GHWP withdraw from IMDRF?
The specific reasoning for GHWP’s withdrawal has not been clarified in the announcement.
Q4. How does this affect medical device regulations?
The withdrawal may alter processes for international collaboration, possibly impacting harmonized approaches to device compliance.
Conclusion
GHWP’s decision to leave IMDRF is a critical update for stakeholders in the medical device industry. Clinical, quality, and regulatory teams should monitor any new developments or guidance documents that emerge to understand their compliance implications.
Organizations should begin assessing how this change may affect their operations, particularly if they collaborate internationally or depend on harmonized regulatory standards.
Disclaimer
This article is intended for informational purposes only and does not constitute legal or professional advice. Always consult with regulatory experts for specific guidance.
Mandatory Information
For full information about the announcement, see the link below.
https://www.imdrf.org/news-events/voluntary-withdrawal-ghwp