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Consultation

Regulatory Authority Assessment Method for Recognition and Surveillance of Medical Device Conformity Assessment Bodies

Regulatory Authority Assessment Method for Recognition and Surveillance of Medical Device Conformity Assessment Bodies, Good Regulatory Review Practices Working Group, Coordinator Melissa Torres, Closed 9 May 2020.

Consultation

Competence and Training Requirements for Regulatory Authority Assessors of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews

Competence and Training Requirements for Regulatory Authority Assessors of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews, Good Regulatory Review Practices Working Group, Closed 26 May 2020.

Consultation

Playbook for Medical Device Regulatory Reliance Programs

A Proposed Document by the International Medical Device Regulators Forum (IMDRF) Good Regulatory Review Practices Working Group is provided below for public comment.

Consultation

Principles and Practices for Software Bill of Materials for Medical Device Cybersecurity

Principles and Practices for Software Bill of Materials (SBOM) for Medical Device Cybersecurity - Good Regulatory Review Practices, Coordinator Dr Aftin Ross

Consultation

IMDRF Principles and Practices for Medical Device Cybersecurity

IMDRF Principles and Practices for Medical Device Cybersecurity, Medical Device Cybersecurity Guide Working Group, Coordinator Suzanne Schwartz, Closed 2 December 2019.

Working group

Integrating patient registries and innovative tools for enhanced medical device evaluation and tracking

Registries of patients undergoing medical device procedures represent a growing potential electronic resource for local and global medical device evaluation and tracking.

Page

Regional Harmonization Initiatives

The International Medical Device Regulators Forum (IMDRF) maintains working relationships with international and regional entities/organizations with mutual interests and goals.

Consultation

Guiding Principles to Support Medical Device Health Equity (N79)

Working group

Medical Device Clinical Evaluation

Improve the effectiveness and efficiency of the pre-market review process by promoting increased global harmonization.

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Official Observers

List of official observers designated by the International Medical Device Regulators Forum (IMDRF) Management Committee (MC).

Member sites

Regulatory Authority Assessment Method for Recognition and Surveillance of Medical Device Conformity Assessment Bodies

Competence and Training Requirements for Regulatory Authority Assessors of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews

Playbook for Medical Device Regulatory Reliance Programs

Principles and Practices for Software Bill of Materials for Medical Device Cybersecurity

IMDRF Principles and Practices for Medical Device Cybersecurity

Integrating patient registries and innovative tools for enhanced medical device evaluation and tracking

Regional Harmonization Initiatives

Guiding Principles to Support Medical Device Health Equity (N79)

Medical Device Clinical Evaluation

Official Observers

Member sites

Regional harmonization initiatives

Official observers

Affiliate members

Affiliates

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Australia

Brazil

Canada

China

European Union

Japan

Russia

Singapore

South Korea

United Kingdom

United States of America

Switzerland

Regional harmonization initiatives

Official observers

Affiliate members

Affiliates