Search

Outcome statement

Ottawa meeting outcome statement

Outcome statement: Ottawa meeting outcome statement

Published date

19 September 2017

Information document

IMDRF RPS WG/N45

Data Exchange Guidelines - Common Data Elements for Medical Device Identification

Information document IMDRF RPS WG/N45FINAL:2017.

Published date

16 March 2017

Information document

IMDRF/Registry WG/N42

Methodological Principles in the Use of International Medical Device Registry Data

(Reclassified - formerly Technical) Information document: IMDRF/Registry WG/N42 FINAL:2017

Published date

16 March 2017

Information document

IMDRF/REGISTRY WG/N33

Principles of International System of Registries Linked to Other Data Sources and Tools

(Reclassified formerly Technical) Information document: IMDRF/REGISTRY WG/N33FINAL:2016

Published date

30 September 2016

Technical document

IMDRF/MDSAP WG/N3

Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition

Technical document: IMDRF/MDSAP WG/N3FINAL:2016 (Edition 2)

Published date

24 March 2016

Technical document

IMDRF/RPS WG/N19

Common Data Elements for Medical Device Identification

Technical document: IMDRF/RPS WG/N19FINAL:2016

Published date

24 March 2016

Technical document

IMDRF/MDSAP WG/N24

Medical Device Regulatory Audit Reports

Technical document: IMDRF/MDSAP WG/N24FINAL:2015

Published date

2 October 2015

Technical document

IMDRF/SaMD WG/N23

Software as a Medical Device (SaMD): Application of Quality Management System

Technical document: IMDRF/SaMD WG/N23FINAL:2015

Published date

2 October 2015

Information document

IMDRF/MDSAP WG/N29

Clarification of the Term "Legal Entity" for MDSAP Recognition Purposes

Information document IMDRF/MDSAP WG/N29FINAL:2015.

Published date

2 October 2015

Information document

IMDRF/NCAR WG/N30

Medical Devices: Post-Market Surveillance -IMDRF National Competent Authority Report (NCAR) Pilot Plan

Information document IMDRF/NCAR WG/N30FINAL:2015.

Published date

2 October 2015

Member sites

Ottawa meeting outcome statement

Data Exchange Guidelines - Common Data Elements for Medical Device Identification

Methodological Principles in the Use of International Medical Device Registry Data

Principles of International System of Registries Linked to Other Data Sources and Tools

Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition

Common Data Elements for Medical Device Identification

Medical Device Regulatory Audit Reports

Software as a Medical Device (SaMD): Application of Quality Management System

Clarification of the Term "Legal Entity" for MDSAP Recognition Purposes

Medical Devices: Post-Market Surveillance -IMDRF National Competent Authority Report (NCAR) Pilot Plan

Member sites

Regional harmonization initiatives

Official observers

Affiliate members

Affiliates

Search

Results

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