International Medical Device Regulators Forum (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 - National Health Surveillance Agency (ANVISA)
Canada - Health Canada
China - China Food and Drug Administration
Europe - European Commission Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs
Japan - Pharmaceuticals and Medical Devices Agency and the Ministry of Health, Labour and Welfare
Russia - Russian Ministry of Health
Singapore - Health Sciences Authority
South Korea - Ministry of Food and Drug Safety
United States - U.S. Food and Drug Administration

The World Health Organization (WHO) is an Official Observer. The Asia Pacific Economic Cooperation (APEC) Life Sciences Innovation Forum's (LSIF) Regulatory Harmonization Steering Committee, the Asian Harmonization Working Party (AHWP), and the Pan American Health Organization (PAHO) are Regional Harmonization Initiatives with IMDRF.

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

Unique Device Identification (UDI),
Personalized Medical Devices,
Standards,
Adverse Event Terminology,
Good Regulatory Review Practices,
Clinical Evaluation, and
Regulated Product Submission.

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 members, observers, 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 (SOP), definitions, 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). In some cases, the IMDRF document(s) may be able to be implemented directly. However, 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 definitions, FDA may adopt these documents through internal usage of these documents. 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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