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Consultation

Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices

Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices, Good Regulatory Review Practices Working Group, Coordinator Melissa Torres - US Food and Drug Administration (FDA), Closed Wednesday, 18 April 2018.

Consultation

Principles of Labeling for Medical Devices and IVD Medical Devices

Principles of Labeling for Medical Devices and IVD Medical Devices, Good Regulatory Review Practices Working Group, Coordinator Melissa Torres - US Food and Drug Administration (FDA), Closed Wednesday, 12 September 2018.

Consultation

Machine Learning-enabled Medical Devices - A subset of Artificial Intelligence-enabled Medical Devices: Key Terms and Definitions

Machine Learning-enabled Medical Devices - Key Terms and Definitions, Artificial Intelligence Medical Devices (AIMD), Coordinator Young-kyu Kang, Closed 29 November 2021

Consultation

Clinical Evidence for IVD Medical Devices – Definitions and Principles of Performance Evaluation

Clinical Evidence for IVD Medical Devices – Definitions and Principles of Performance Evaluation

Consultation

Definitions for Personalized Medical Devices

Definitions for Personalized Medical Devices, Personalized Medical Devices (PMD) Working Group, Coordinator Tracey Duffy, Closed 24 May 2018.

Consultation

Personalized Medical Devices - Regulatory Pathways

Personalized Medical Devices - Regulatory Pathways, Personalized Medical Devices (PMD) Working Group, Coordinator Tracey Duffy, Closed 24 July 2019.

Consultation

Personalized Medical Devices Regulatory Pathways

Personalized Medical Devices Regulatory Pathways - Personalized Medical Devices

Consultation

Personalized Medical Devices Production Verification and Validation

Personalized Medical Devices Production Verification and Validation, Personalized Medical Devices

Consultation

Principles and Practices for the Cybersecurity of Legacy Medical Devices

Principles and Practices for the Cybersecurity of Legacy Medical Devices, Medical Device Cybersecurity Guide, Coordinator Dr Aftin Ross, Closes 3 July 2022

Consultation

Principles of In Vitro Diagnostic (IVD) Medical Devices Classification

Principles of In Vitro Diagnostic (IVD) Medical Devices Classification, Principles of In Vitro Diagnostic (IVD) Medical Devices Classification Working Group, Coordinator Tatyana Buryakina, Closed 25 July 2020.

Member sites

Therapeutic Goods Administration

Brazilian Health Regulatory Agency (ANVISA)

National Medical Products Administration

European Commission - Directorate-General for Health and Food Safety

Pharmaceutical and Medical Devices Agency (PMDA)

Ministry of Health, Labour and Welfare (MHLW)

Russian Ministry of Health

Health Sciences Authority

Ministry of Food and Drug Safety

Medicines and Healthcare products Regulatory Agency

US Food and Drug Administration

Regional harmonization initiatives

APEC Regulatory Harmonization Steering Committee (RHSC)

Pan American Health Organization (PAHO)

African Medical Devices Forum (AMDF)

Official observers

Argentina, National Administration of Drugs, Food and Medical Devices

The World Health Organization (WHO)

Saudi Arabia, Saudi Food and Drug Authority

Affiliate members

Botswana - Botswana Medicines Regulatory Authority (BoMRA)

Chile - Public Health Institute of Chile (ISP)

Chinese Taipei - Taiwan Food and Drug Administration (TFDA)

Colombia - Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA)

Costa Rica - Ministry of Health (MoH)

Cuba - Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos (CECMED)

Dominican Republic - General Directorate of Medicines, Food and Health Products (DIGEMAPS)

Egypt - Egyptian Drug Authority (EDA)

El Salvador - Sanitary Regulation Superintendency (SRS)

Ethiopia - Ethiopian Food and Drug Authority (EFDA)

Ghana - Foods and Drug Authority (Ghana)

India - Central Drugs Standard Control Organization (CDSCO)

Indonesia - Ministry of Health (MoH)

Israel - The Medical Technology, Health Information, Innovation and Research Directorate (MTIIR)

Affiliates

Jordan - Jordan Food and Drug Administration (JFDA)

Kenya - Pharmacy and Poisons Board (PPB)

Malaysia - Medical Device Authority (MDA)

Mexico - Federal Commission for Protection from Sanitary Risks (COFEPRIS)

Montenegro - Institute for Medicine and Medical Devices of Montenegro (CINMED)

Nigeria - National Agency for Food and Drug Administration Control (NAFDAC)

Oman - Drug Safety Center, Medical Device Control Department (DSC)

Paraguay - National Health Surveillance (DINAVISA)

Peru - General Directorate of Medicines, Supplies and Drugs (DIGEMID)

Philippines - Food and Drug Administration (FDA)

South Africa - South African Health Products Regulatory Authority (SAHPRA)

Tanzania - Tanzania Medicines and Medical Devices Authority (TMDA)

Uzbekistan - The Center for Pharmaceutical Products Safety

Zanzibar - Zanzibar Food and Drug Agency (ZFDA)

Zimbabwe - Medicines Control Authority (MCAZ)