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Working group

Standards - Improving the quality of international medical device standards for regulatory use

Improve the process of developing international standards used for regulatory purpose in the medical technology domain.

Working group

Unique Device Identification (UDI) Application Guide

Development of non-binding rules for creating, using, and maintaining unique device identifiers and related activities.

Working group

Software as a Medical Device (SaMD)

Develop international definitions, risk category framework, and quality management system.

Working group

A review of the NCAR system

Review the GHTF NCAR Exchange Program and to advise on opportunities for improvement

Working group

Medical device single audit program (MDSAP)

Leverage regulatory resources to manage an efficient, effective, and sustainable single audit program.

Working group

IMDRF recognized standards

IMDRF recognized standards.

Working group

Roadmap for implementation of UDI system

Development of non-binding rules for creating, using, and maintaining unique device identifiers and related activities.

Outcome statement

Moscow meeting outcome statement

Outcome statement: Moscow meeting outcome statement

Outcome statement

China (Beijing) meeting outcome statement

Outcome statement: China (Beijing) meeting outcome statement

Outcome statement

China meeting outcome statement

Outcome statement: China meeting outcome statement

Member sites

Standards - Improving the quality of international medical device standards for regulatory use

Unique Device Identification (UDI) Application Guide

Software as a Medical Device (SaMD)

A review of the NCAR system

Medical device single audit program (MDSAP)

IMDRF recognized standards

Roadmap for implementation of UDI system

Moscow meeting outcome statement

China (Beijing) meeting outcome statement

China meeting outcome statement

Member sites

Regional harmonization initiatives

Official observers

Affiliate members

Affiliates

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Member sites

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