International Medical Device Regulators Forum (IMDRF)

Update: September 24, 2024 – The FDA, as the Chair and Secretariat of the International Medical Device Regulators Forum (IMDRF) in 2024, hosted the 26th session of IMDRF from September 16 through September 20, 2024. For more details, visit IMDRF.

The International Medical Device Regulators Forum (IMDRF) is a group of medical device regulators from around the world that have voluntarily come together to harmonize the regulatory requirements for medical products that vary from country to country.

The current IMDRF members represent medical device regulatory authorities in:

Australia - Therapeutic Goods Administration
Brazil - Brazilian Health Regulatory Agency (ANVISA)
Canada - Health Canada
China - National Medical Products Administration
European Union - European Commission - Directorate-General for Health and Food Safety
Japan - Pharmaceuticals and Medical Devices Agency and the Ministry of Health, Labour and Welfare
Singapore - Health Sciences Authority
South Korea - Ministry of Food and Drug Safety
United Kingdom - Medicines and Healthcare products Regulatory Agency
United States - U.S. Food and Drug Administration

The World Health Organization (WHO), Argentina, Saudi Arabia, and Switzerland are Official Observers. The Asia Pacific Economic Cooperation (APEC) Life Sciences Innovation Forum's (LSIF) Regulatory Harmonization Steering Committee, the Global Harmonization Working Party (GHWP), the Pan American Health Organization (PAHO), and the African Medical Devices Forum (AMDF) are Regional Harmonization Initiatives with IMDRF. IMDRF Affiliate Members include medical device regulatory authorities from Botswana, Chile, Chinese Taipei, Costa Rica, Cuba, Dominican Republic, Egypt, El Salvador, Ethiopia, India, Israel, Jordan, Kenya, Mexico, Montenegro, Nigeria, Oman, Paraguay, Peru, South Africa, Tanzania, and Zimbabwe.

As the U.S. member, the FDA actively participates in the IMDRF management committee as well as on IMDRF working groups including:

Adverse Event Terminology,
Artificial Intelligence/Machine Learning-Enabled,
Good Regulatory Review Practices,
Personalized Medical Devices,
Quality Management Systems (QMS),
Regulated Product Submission, and
Software as a Medical Device (SaMD).

IMDRF develops internationally agreed-upon documents related to a wide variety of topics affecting medical devices. Draft IMDRF documents are available for public review and comment for a period of 60-90 days. IMDRF Management Committee members, observers, affiliate members, regional harmonization initiatives and affiliate organizations will often solicit feedback from their stakeholders on these draft documents. In some cases—such as when the IMDRF document conveys guidance—the FDA may also solicit feedback on the draft IMDRF documents by publishing a notice of availability of the guidance for public comment in the Federal Register.

When finalized, IMDRF members adopt these documents where appropriate, and in some cases adapt them to meet the regulatory requirements of their jurisdictions. Because IMDRF documents vary in nature, from standard operating procedures (SOPs) and terminology to policy documents, FDA adoption of these documents will differ depending on the type of document. For example, the FDA may adopt an IMDRF document that describes policies as an FDA guidance document, when the document meets the definition of an FDA guidance document (per 21 CFR 10.115). Since the policies and concepts within IMDRF documents are often broad, FDA may also issue additional guidance documents or update existing guidance documents to include information regarding the adoption and implementation of the policies and concepts in IMDRF documents within the FDA’s regulatory framework.

For other non-guidance IMDRF documents, such as SOPs or terminology, the FDA may adopt these documents by incorporating them into existing medical device regulatory practices. The FDA committed to assess the extent of CDRH implementation of IMDRF documents and report this information publicly as part of the Medical Device User Fee Amendments of 2022 (MDUFA V). The FDA will work collaboratively with industry and other members of the medical device ecosystem to implement these harmonized documents and help assure that safe and effective medical devices are available to patients in the U.S. and globally.

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