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Meetings
The next IMDRF meeting will take place in Beijing, China in September 2018. The Management Committee has reviewed the format of its agendas and agreed that for future meetings the Stakeholder Open Forum will be held on Day 1 rather than Day 2 of its meetings, and that more time will be allocated to the Management Committee's closed session discussions. These changes will be implemented from meeting no. 14, with the Open Stakeholder Forum to be held on 18 September 2018. All interested parties are invited to attend this Forum. Further meeting details, including a registration link, will be available soon.
We are grateful for your continued interest in the work of IMDRF.
For a list of GHTF meeting minutes, see the GHTF Archived Documents page.
Upcoming meetings
| Meeting no. |
Location |
Date |
Links |
| 14 |
Beijing, China |
18-20 September 2018 |
|
Past meetings
| Meeting no. |
Location |
Date |
Links |
| 13 |
Shanghai, China |
20-22 March 2018 |
China meeting outcome statement - PDF (382kb) China meeting outcome statement - DOCX (75kb) Registration form - IMDRF Open Stakeholder Day
DITTA Workshop Registration
DITTA Workshop Presentations - Monday 19 March 2018
China Stakeholder Forum Agenda - Wednesday 21 March 2018 - PDF (475kb) IMDRF Presentation - Jurisdictional Update - Australia - PDF (268kb) IMDRF Presentation - Jurisdictional Update - Brazil - ANVISA - PDF (322kb) IMDRF Presentation - Jurisdictional Update - Canada - PDF (116kb) IMDRF Presentation - Jurisdictional Update - China - PDF (262kb) IMDRF Presentation - Jurisdictional Update - EU - PDF (184kb) IMDRF Presentation - Jurisdictional Update - Japan - PDF (1.82Mb) IMDRF Presentation - Jurisdictional Update - Russia - PDF (567kb) IMDRF Presentation - Jurisdictional Update - Singapore - PDF (277kb) IMDRF Presentation - Jurisdictional Update - South Korea - PDF (1.37Mb) IMDRF Presentation - Jurisdictional Update - US - PDF (449kb) IMDRF Presentation - Stakeholder - CAMDI update - PDF (442kb) IMDRF Presentation - Stakeholder - DITTA update - PDF (878kb) IMDRF Presentation - Stakeholder - GMTA update - PDF (391kb) IMDRF Presentation - Stakeholder - PAHO update - PDF (898kb) IMDRF Presentation - Stakeholder - Saudi Arabia update - PDF (859kb) IMDRF Presentation - Stakeholder - WHO update - PDF (339kb) IMDRF Presentation - Working Group Update - Adverse Event Terminology - PDF (304kb) IMDRF Presentation - Working Group Update - Good Regulatory Review Practices - PDF (619kb) IMDRF Presentation - Working Group Update - Patient Registry - PDF (208kb) IMDRF Presentation - Working Group Update - Personalized Medical Devices - PDF (612kb) IMDRF Presentation - Working Group Update - Regulated Products Submission - PDF (192kb) IMDRF Presentation - Working Group Update - Standards - PDF (545kb) IMDRF Presentation - Working Group Update - Unique Device Identification - PDF (436kb) |
| 12 |
Ottawa, Canada |
19-21 September 2017 |
Ottawa meeting outcome statement - PDF (41kb) Ottawa meeting outcome statement - DOCX (75kb) IMDRF Open Stakeholder Day
Presentations from DITTA workshops 18 September
IMDRF Stakeholder Forum Agenda - Wednesday 20 September 2017 - PDF (421kb) IMDRF Presentation - Jurisdictional Update - Australia - PDF (683kb) IMDRF Presentation - Jurisdictional Update - Brazil - ANVISA - PDF (362kb) IMDRF Presentation - Jurisdictional Update - Canada - PDF (115kb) IMDRF Presentation - Jurisdictional Update - China - PDF (307kb) IMDRF Presentation - Jurisdictional Update - EU - PDF (251kb) IMDRF Presentation - Jurisdictional Update - Russia - PDF (1.19Mb) IMDRF Presentation - Jurisdictional Update - Japan - PDF (474kb) IMDRF Presentation - Jurisdictional Update - Singapore - PDF (748kb) IMDRF Presentation - Jurisdictional Update - US - PDF (661kb) IMDRF Presentation - New Work Item Proposal - Definitions for Patient-Specific, Customized and Custom-made Medical Devices - PDF (292kb) IMDRF Presentation - Real World Evidence panel - CADTH and Clinician - PDF (1.90Mb) IMDRF Presentation - Real World Evidence panel - Industry - PDF (561kb) IMDRF Presentation - Real World Evidence panel - NESTcc overview - PDF (753kb) IMDRF Presentation - Stakeholder - AHWP update - PDF (1.62Mb) IMDRF Presentation - Stakeholder - APEC update - PDF (991kb) IMDRF Presentation - Stakeholder - DITTA update - PDF (897kb) IMDRF Presentation - Stakeholder - GMTA update - PDF (694kb) IMDRF Presentation - Stakeholder - PAHO update - PDF (1.08Mb) IMDRF Presentation - Stakeholder - WHO update - PDF (800kb) IMDRF Presentation - Working Group Update - Adverse Events Terminology - PDF (339kb) IMDRF Presentation - Working Group Update - Good Regulatory Review Practices - PDF (421kb) IMDRF Presentation - Working Group Update - NCAR - PDF (141kb) IMDRF Presentation - Working Group Update - Registries - PDF (115kb) IMDRF Presentation - Working Group Update - Regulated Product Submission - PDF (335kb) IMDRF Presentation - Working Group Update - Software as a Medical Device (SaMD) - PDF (1.14Mb) IMDRF Presentation - Working Group Update - Standards - PDF (561kb) |
| 11 |
Vancouver, Canada |
14-16 March 2017 |
Vancouver meeting outcome statement - PDF (137kb) Vancouver meeting outcome statement - DOCX (74kb) Open Stakeholder Day Registration Form
DITTA Workshop Registration Form IMDRF Stakeholder Forum Draft Agenda 15 March 2017 - PDF (146kb) IMDRF Presentation - Jurisdictional update - Australia - PDF (58kb) IMDRF Presentation - Jurisdictional update - Brazil ANVISA - PDF (117kb) IMDRF Presentation - Jurisdictional update - Health Canada - PDF (72kb) IMDRF Presentation - Jurisdictional update - China - PDF (94kb) IMDRF Presentation - Jurisdictional update - EU - PDF (89kb) IMDRF Presentation - Jurisdictional update - Japan - PDF (1.08Mb) IMDRF Presentation - Jurisdictional update - Russia - PDF (1.13Mb) IMDRF Presentation - Jurisdictional update - Singapore - PDF (143kb) IMDRF Presentation - Jurisdictional update - US - PDF (165kb) IMDRF Presentation - Working Group update - Good Regulatory Review Practices - PDF (212kb) IMDRF Presentation - Working Group update - Adverse Event Terminology - PDF (346kb) IMDRF Presentation - Working Group update - NCAR Pilot Exchange Stats Oct 2015-Jan 2017 - PDF (193kb) IMDRF Presentation - Working Group update - NCAR - PDF (65kb) IMDRF Presentation - Working Group update - Registries - PDF (1.34Mb) IMDRF Presentation - Working Group update - RPS - PDF (125kb) IMDRF Presentation - Working Group update - SaMD Clinical Evaluation - PDF (720kb) IMDRF Presentation - Working Group update - Standards - PDF (512kb) IMDRF Presentation - Stakeholder - AHWP update - PDF (1.49Mb) IMDRF Presentation - Stakeholder - APEC update - PDF - (581kb) IMDRF Presentation - Stakeholder - DITTA update - PDF (592kb) IMDRF Presentation - Stakeholder - GMTA update - PDF (173kb) IMDRF Presentation - Stakeholder - PAHO update - PDF (1.16Mb) IMDRF Presentation - Stakeholder - WHO update - PDF (304kb) IMDRF Presentation - New Work Item Proposal - GMTA - PDF (72kb) |
| 10 |
Brazil |
13-15 September 2016 |
Florianópolis meeting outcome statement - PDF (373kb) Florianópolis meeting outcome statement - DOCX (70kb) IMDRF Presentation - 5 years of IMDRF - PDF (148kb) IMDRF Presentation - Brazilian System for Conformity Assessment - Brazil - PDF (392kb) IMDRF Presentation - ISO 14155 2011 Clinical investigation of MD for human subjects - Japan - PDF (609kb) IMDRF Presentation - Jurisdictional update - Brazil - PDF (132kb) IMDRF Presentation - Jurisdictional update - Canada - PDF (110kb) IMDRF Presentation - Jurisdictional update - China - PDF (164kb) IMDRF Presentation - Jurisdictional update - EU - PDF (127kb) IMDRF Presentation - Jurisdictional update - Japan - PDF (889kb) IMDRF Presentation - Jurisdictional update - Russia - PDF (215kb) IMDRF Presentation - Jurisdictional update - USA - PDF (600kb) IMDRF Presentation - MDSAP - Pilot update - ANVISA Brazil - PDF (288kb) IMDRF Presentation - Good Regulatory Practice - experience and challenges - ANVISA Brazil - PDF (4.13Mb) IMDRF Presentation - RPS - Pilot ToC industry feedback and impression - Johnson & Johnson - PDF (462kb) IMDRF Presentation - Stakeholder - AHWP update - PDF (1.23Mb) IMDRF Presentation - Stakeholder - DITTA update - PDF (697kb) IMDRF Presentation - Stakeholder - GMTA update - PDF (1.03Mb) IMDRF Presentation - Stakeholder - PAHO update - PDF (1.14Mb) IMDRF Presentation - Stakeholder - WHO update - PDF (380kb) IMDRF Presentation - UDI Implementation update - USA - PDF (1.15Mb) IMDRF Presentation - Working Group update - Adverse Event Terminology - PDF (271kb) IMDRF Presentation - Working Group update - Good Regulatory Review Practices - PDF (629kb) IMDRF Presentation - Working Group update - Improving Quality of International Standards - PDF (406kb) IMDRF Presentation - Working Group update - Medical Device Patient Registries - PDF (541kb) IMDRF Presentation - Working Group update - Regulated Product Submission (RPS) - PDF (143kb) IMDRF Presentation - Working Group update - Software as a Medical Device (SaMD) Clinical Evaluation - PDF (1.28Mb) IMDRF Presentation - Working Group update - NCAR - PDF (142kb) |
| 9 |
Brasilia, Brazil |
8 to 10 March 2016 |
Brazil meeting outcome statement - PDF (92kb) Brazil meeting outcome statement - DOCX (70kb) IMDRF Presentation - Jurisdictional update - Australia - PDF (73kb) IMDRF Presentation - Jurisdictional update - Brazil - PDF (109kb) IMDRF Presentation - Jurisdictional update - Canada - PDF (99kb) IMDRF Presentation - Jurisdictional update - China - PDF (129kb) IMDRF Presentation - Jurisdictional update - EU - PDF (122kb) IMDRF Presentation - Jurisdictional update - Japan - PDF (319kb) IMDRF Presentation - Jurisdictional update - Russia - PDF (346kb) IMDRF Presentation - Jurisdictional update - USA - PDF (585kb) IMDRF Presentation - Update on AHWP Work - PDF (784kb) IMDRF Presentation - Updates of APEC - PDF (355kb) IMDRF Presentation - Regulatory Convergence on Medical Devices - An International Trade Approach - PDF (660kb) IMDRF Presentation - DITTA Contribution to IMDRF Stakeholder Forum - PDF (476kb) IMDRF Presentation - GMTA -Getting innovative medical technologies to patients - How IMDRF matters - PDF (594kb) IMDRF Presentation - PAHO - Update on the Regional Working Group - PDF (879kb) IMDRF Presentation - The Regulation of Medical Devices in Mercosur - PDF (261kb) IMDRF Presentation - Update on WHO work - PDF (180kb) IMDRF Presentation - Regulated Products Working Group - PDF (228kb) IMDRF Presentation - Adverse Event Terminology and Coding Working Group - PDF (114kb) IMDRF Presentation - Good Regulatory Review Practices Working Group Update - PDF (372kb) IMDRF Presentation - Medical Device Single Audit Program Working Group Update - PDF (349kb) IMDRF Presentation - Medical Device Single Audit Program (MDSAP) Pilot Update - PDF (259kb) IMDRF Presentation - National Competent Authority Report Exchange Programme - PDF (112kb) IMDRF Presentation - NCAR Performance / Statistics - January to 30th September 2015 - PDF (401kb) IMDRF Presentation - Integrating Device Registries and Innovative Tools for Medical Device Evaluation - PDF (512kb) IMDRF Presentation - Software as a Medical Device (SaMD)Application of Clinical Evaluation - PDF (606kb) IMDRF Presentation - IMDRF ToC Pilot - PDF (81kb) |
| 8 |
Kyoto, Japan |
Week of 14 September 2015 |
Kyoto meeting outcome statement - PDF (52kb) Kyoto meeting outcome statement - DOCX (71kb) IMDRF Presentation - Adverse Event Terminology and Coding Working Group update - PDF (77kb) IMDRF Presentation - AHWP Activity update - PDF (714kb) IMDRF Presentation - DITTA contribution to stakeholder forum - PDF (629kb) IMDRF Presentation - Jurisdictional update - Brazil - PDF (79kb) IMDRF Presentation - Jurisdictional update - Canada - PDF (66kb) IMDRF Presentation - Jurisdictional update - Japan - PDF (358kb) IMDRF Presentation - Jurisdictional update - US - PDF (187kb) IMDRF Presentation - Jurisdictional update - EU - PDF (115kb) IMDRF Presentation - MDSAP Working Group update - PDF (83kb) IMDRF Presentation - NCAR update - PDF (103kb) IMDRF Presentation - QA session - PDF (70kb) IMDRF Presentation - RPS - Table of Contents update - PDF (68kb) IMDRF Presentation - RPS Working Group update - PDF (240kb) IMDRF Presentation - SaMD Survey Results update - PDF (1.15Mb) IMDRF Presentation - SaMD Working Group update - PDF (495kb) IMDRF Presentation - WHO update - PDF (806kb) IMDRF Presentation - NCAR Implementation update - PDF (497kb) IMDRF Presentation - GMTA update - PDF (271kb) IMDRF Presentation - RPS Panel discussion - PDF (146kb) IMDRF Presentation - PAHO update - PDF (742kb) IMDRF Presentation - APEC LSIF RHSC update - PDF (158kb) IMDRF Presentation - Jurisdictional update - Australia - PDF (56kb) IMDRF Presentation - Jurisdictional update - Russia - PDF (267kb) IMDRF Presentation - Jurisdictional update - China - PDF (69kb) IMDRF Presentation - Device Registries update - PDF - (280kb) IMDRF Presentation - NCAR Workshop NMA update - PDF (138kb) |
| 7 |
Tokyo, Japan |
24-26 March 2015 |
Tokyo meeting outcome statement - PDF (57kb) Tokyo meeting outcome statement - DOCX (70kb) IMDRF Presentation - Introduction of AHWP - PDF (534kb) IMDRF Presentation - Update on APEC LSIF RHSC - PDF (100kb) IMDRF Presentation - Update on China medical device regulatory - PDF (78kb) IMDRF Presentation - Medical Device Single Audit Program (MDSAP) Pilot Update - PDF (63kb) IMDRF Presentation - PAHO - Regulation of Medical Devices: a Regional approach - PDF (508kb) IMDRF Presentation - New Aspects in MD Regulations in the Russian Federation - PDF (364kb) IMDRF Presentation - Update on WHO work - PDF (173kb) IMDRF Presentation - Development of common terminology and code related to adverse event of medical device - NWI proposal sub committee report - PDF (113kb) IMDRF Presentation - DITTA contribution to IMDRF Stakeholder Forum - PDF (276kb) IMDRF Presentation - NWIP - Recognized Standards Phase II - PDF 12 March 2015 - PDF (240kb) IMDRF Presentation - Australian jurisdictional update - PDF (48kb) IMDRF Presentation - Regulatory update - ANVISA - PDF (58kb) IMDRF Presentation - Implementation of PMD Act - Japan Update - PDF (256kb) IMDRF Presentation - Update on EU regulatory developments - PDF (56kb) IMDRF Presentation - National Competent Authority Report Exchange Programme - PDF (63kb) IMDRF Presentation - Integrating Device Registries, UDI and Innovative Tools for Medical Device Evaluation - PDF (202kb) IMDRF Presentation - Regulated Products Working Group - Table of Contents Work Stream - PDF (66kb) IMDRF Presentation - RPS WG Update - PDF (123kb) IMDRF Presentation - Software as a Medical Device (SaMD) - Application of Quality Management System - PDF (708kb) IMDRF Presentation - Medical Device Single Audit Program (MDSAP) Working Group - PDF (56kb) IMDRF Presentation - Regulatory and Policy Updates - Health Canada - PDF (50kb) IMDRF Presentation - GMTA Collaboration with IMDRF: Third Anniversary - PDF (252kb) IMDRF Presentation - U.S. FDA Center for Devices and Radiological Health Update - PDF (207kb) |
| 6 |
Washington D.C, USA |
16-18 September 2014 |
IMDRF Washington D.C meeting outcome statement - PDF (57kb) IMDRF Washington D.C meeting outcome statement - DOCX (66kb) IMDRF Presentation - Australian jurisdictional update - PDF (57kb) IMDRF Presentation - Update on the Brazilian regulatory aspects on medical devices - PDF (79kb) IMDRF Presentation - Regulatory and Policy Updates - Therapeutic Products Directorate - Health Canada - PDF (64kb) IMDRF Presentation - Update on EU regulatory developments - PDF (67kb) IMDRF Presentation - New Direction of Japanese Regulations on MD/IVD - Japan Update - PDF (244kb) IMDRF Presentation - U.S. FDA Center for Devices and Radiological Health update - PDF (357kb) IMDRF Presentation - RPS Work Item: Beta Testing of Message Standard - PDF (177kb) IMDRF Presentation - New Work Item Proposal - Harmonization of Good Clinical Practices - PDF (109kb) IMDRF Presentation - Medical Device Single Audit Program (MDSAP) Working Group - PDF (75kb) IMDRF Presentation - Software as a Medical Device (SaMD): Possible Framework for Risk Categorization and Corresponding Considerations - Proposed Final - PDF (333kb) IMDRF Presentation - Development of common terminology and code related to adverse event of medical device - PDF (105kb) IMDRF Presentation - RPS Work Item: Table of Contents - PDF (87kb) |
| 5 |
San Fransisco, CA, USA |
25-27 March 2014 |
IMDRF - San Fransisco meeting outcome statement - PDF (33kb) IMDRF Presentation - Final Report Phase One: "List of international standards recognized by IMDRF management committee members" - PDF (104kb) IMDRF Presentation - Regulatory update: Europe - PDF (84kb) IMDRF Presentation - Regulatory update: Australia - PDF (62kb) IMDRF Presentation - Regulatory update: Brazil - PDF (72kb) IMDRF Presentation - Regulatory update: Canada - PDF (82kb) IMDRF Presentation - Regulatory update: Japan - PDF (387kb) IMDRF Presentation - Regulatory update: United States of America - PDF (166kb) IMDRF Presentation - RPS Work Item: Beta Testing of Message Standard - PDF (144kb) IMDRF Presentation - Medical Device Single Audit Program (MDSAP) Working Group - PDF (76kb) IMDRF Presentation - IMDRF Work Item National Competent Authority Report Exchange Criteria and Report Form - PDF (80kb) IMDRF Presentation - Software as a Medical Device (SaMD) - PDF (337kb) IMDRF Presentation - RPS Work Item: International Harmonized Structures (formerly Table of Contents) - PDF (105kb) IMDRF Annual report 2013 - PDF (189kb) |
| 4 |
Brussels, Belgium |
12-14 November 2013 |
IMDRF Brussels meeting outcome statement - PDF (31kb) IMDRF Brussels meeting outcome statement - DOC (76kb) IMDRF Presentation - Update on the Brazilian regulatory aspects on medical devices - PDF (177kb) IMDRF Presentation - Update on medical device regulations - PDF (85kb) IMDRF Presentation - Innovation for Safety: Achievements and challenges - PDF (686kb) IMDRF Presentation - Medical devices in diabetes care - PDF (775kb) IMDRF Presentation - Patients as partners for the safety of innovative medical devices - PDF (698kb) IMDRF Presentation - Update on EU regulatory developments - PDF (80kb) IMDRF Presentation - GMTA Perspective Continuous improvement product safety and performance - PDF (516kb) IMDRF Presentation - Administration in the sphere of circulation - PDF (602kb) IMDRF Presentation - Innovation for Safety: achievements and challenges A notified body perspective - PDF (808kb) IMDRF Presentation - US FDA Center for Devices and Radiological Health - Update - PDF (103kb) |
| 3 |
Nice, France |
19-21 March 2013 |
IMDRF France meeting outcome statement - PDF (60kb) IMDRF France meeting outcome statement - DOC (159kb) IMDRF Presentation - GHTF to IMDRF What's next? - PDF (962kb) IMDRF Presentation - Regulatory convergence WHO's perspective - PDF (954kb) IMDRF Presentation - International Regulatory Convergence: Challenges of the Global Health System - PDF (473kb) IMDRF Presentation - International Regulatory Convergence: Meeting Patients' Needs - PDF (274kb) IMDRF Presentation - International Regulatory Convergence: strategic reflections from the ESC - PDF (1.6Mb) IMDRF Presentation - AHWP - IMDRF Articulation Towards Regulatory Convergence - PDF (248kb) IMDRF Presentation - DITTA - IMDRF Stakeholders Meeting - PDF (551kb) IMDRF Presentation - Definition and regulation in terms of mechanism of action and intended use - PDF (246kb) IMDRF Presentation - Regulatory guidance for validation and approval of standardized apheresis connectors - PDF (203kb) IMDRF Presentation - IMDRF RPS ToC WG Update - PDF (266kb) IMDRF Presentation - IMDRF RPS Update - PDF (349kb) IMDRF Presentation - IMDRF Project: List of international standards recognized by IMDRF management committee members - PDF (153kb) IMDRF Presentation - Medical Device Single Audit Program (MDSAP) Working Group - PDF (79kb) IMDRF Presentation - Unique Device Identification for medical devices and in vitro diagnostics medical devices - PDF (1.5Mb) IMDRF Presentation - Review of the NCAR Exchange Program - PDF (155kb) IMDRF Presentation - China: Update on jurisdictional regulatory developments - PDF (113kb) IMDRF Presentation - Update on the Brazilian regulatory aspects on medical devices - PDF (184kb) IMDRF Presentation - Revision of the EU legislation on medical devices and in vitro diagnostic medical devices - PDF (569kb) |
| 2 |
Sydney, Australia |
25-27 September 2012 |
IMDRF Sydney meeting outcome statement - PDF (63kb) IMDRF Sydney meeting outcome statement - DOC (160kb) List of international standards recognized by IMDRF management committee members - PDF (61kb) Roadmap for Implementation of UDI System - PDF (220kb) The Regulated Product Submission: Progress Update - PDF (40kb) Revision of the NCAR Exchange Program - PDF (66kb) International Medical Device Regulators Forum (IMDRF)and Medical Device Single Audit Program (MDSAP) Working Group - PDF (30kb) Letter to RPS Vendors - PDF (85kb) |
| 1 |
Singapore |
28 February - 1 March 2012 |
IMDRF Singapore meeting outcome statement - PDF (56kb) IMDRF Singapore meeting outcome statement Word document (58kb) IMDRF Singapore meeting media release - PDF (167kb) IMDRF Singapore meeting media release - DOCX (13kb) |
| - |
Ottawa, Canada |
6-7 October 2011 |
IMDRF Ottawa meeting outcome statement - PDF (52kb) IMDRF Ottawa meeting outcome statement - DOC (63kb) |
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