The International Medical Device Regulators Forum (IMDRF) has introduced an important update for medical device regulatory authorities worldwide. The announcement of a new affiliate membership category, made on September 30, 2025, marks a pivotal step in fostering collaboration within the global regulatory community. This development enables regulatory entities to gain closer access to IMDRF resources and activities, enhancing their participation in shaping global standards. Regulatory, clinical, and quality professionals should take note of this opportunity as it may influence the future of international medical device oversight.
In this article:
What changed?
IMDRF announced the introduction of the Affiliate Membership category. This new status allows regulatory authorities—not previously part of the core IMDRF membership—to join as affiliates. Affiliate Members gain the ability to attend IMDRF Management Committee Open Meetings and contribute to open Working Groups. This change reflects IMDRF’s ongoing commitment to inclusivity and collaboration within the regulatory landscape.
Previously, opportunities to engage with IMDRF discussions were limited to full members, which include representatives from established regulatory authorities in major jurisdictions. The introduction of Affiliate Membership broadens access for agencies seeking a clearer understanding of IMDRF processes while contributing technical expertise and insights.
How to apply?
Regulatory authorities interested in Affiliate Membership must submit their applications by completing the designated form provided by IMDRF. Applications must be submitted directly to the IMDRF Chair for consideration. The organization encourages thorough documentation when preparing the application to ensure alignment with its stated criteria.
- Step 1: Download the official application form from the IMDRF website.
- Step 2: Complete the form with details about the regulatory authority and its mission.
- Step 3: Submit the application form via the specified channels to the IMDRF Chair.
For complete guidance on application procedures, IMDRF advises referencing the Standard Operating Procedures document available on its website.
Who benefits?
The new Affiliate Membership category primarily targets regulatory bodies that oversee medical devices but have not been involved with IMDRF as full members. Participation as an affiliate enables members to benefit from:
- Access to open meetings of the IMDRF Management Committee, fostering better understanding of international regulatory processes.
- Involvement in open Working Groups where members collaborate on initiatives that shape global standards.
- Engagement with a network of regulators that share best practices and insights for improving oversight frameworks.
This opportunity enhances inclusivity by fostering collaboration across regions, which benefits the entire medical device ecosystem, including manufacturers, healthcare professionals, and end-users.
Frequently Asked Questions
Q1: What types of organizations qualify to become Affiliate Members?
Any regulatory authority responsible for medical device oversight that is not currently part of the IMDRF membership may apply for affiliate status.
Q2: Are there fees associated with Affiliate Membership?
The official announcement does not specify fees, but applicants should reference IMDRF Standard Operating Procedures for details.
Q3: Can Affiliate Members vote in IMDRF decisions?
No, Affiliate Members can attend open meetings and working groups but do not have voting rights.
Conclusion
The IMDRF Affiliate Membership represents a valuable opportunity for regulatory authorities to engage with international medical device regulation efforts. This inclusive approach allows for broader participation in discussions that shape policy and standards. Regulatory professionals should carefully evaluate this opening and consider submitting their applications promptly.
Disclaimer
This article is intended for informational purposes only and should not be construed as legal advice. For precise legal guidance, consult applicable regulatory frameworks or legal counsel.