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In Vitro Diagnostic Device Regulatory Submission Table of Contents (IVD ToC)

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Regulated Product Submission

A Proposed Document by the International Medical Device Regulators Forum (IMDRF) Regulated Product Submission Working Group is provided below for public comment.

Thank you for your contribution in reviewing and providing feedback for this document.

Consultation documents

In Vitro Diagnostic Device Regulatory Submission Table of Contents (IVD ToC)

Please use the comments template to provide comments on the Proposed Document and send comments to Patrick Axtell and Daniel Yoon via email: patrick.axtell [at] fda.hhs.gov (patrick[dot]axtell[at]fda[dot]hhs[dot]gov)  and daniel.yoon [at] hc-sc.gc.ca (daniel[dot]yoon[at]hc-sc[dot]gc[dot]ca)  with the subject line 'Public Consultation on IVD Table of Contents’ Working draft.

Comments Table Template - IMDRF N13 (IVD ToC) RPS WG

Member sites

Regional harmonization initiatives

APEC LSIF Regulatory Harmonization Steering Committee

Global Harmonization Working Party (GHWP)

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

Switzerland, Swissmedic

Affiliate members

Botswana - Botswana Medicines Regulatory Authority (BoMRA)

Chile - Public Health Institute of Chile (ISP)

Chinese Taipei Taiwan Food and Drug Administration (TFDA)

Costa Rica - Ministry of Health

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)

India - Central Drugs Standard Control Organization (CDSCO)

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)

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)

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

Tanzania - Tanzania Medicines and Medical Devices Authority (TMDA)

Zimbabwe - Medicines Control Authority (MCAZ)