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Meetings

Details on the venue and on the Stakeholder Forum will be communicated on this page.

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

IMDRF - DITTA Joint Virtual Workshop

Tuesday, 16 March 2021
(12:00 to 14:00 CET - 20:00 to 22:00 Korean time - 06:00 to 08:00 EST the starting time observing the Daylight Saving Time (DST) for North American Countries to ET 7:00 am)

Meeting no. Location Date Links
19 Virtual Workshop 16 March 2021 The website has opened for registration, and meeting materials for the IMDRF-DITTA Joint Workshop on March 16 and the IMDRF Stakeholders Forum on March 23 are available at: www.2021imdrf.or.kr
The contact point for inquiries regarding registration and technical matters for the meeting platform - please email: contact@2021imdrf.or.kr

Past meetings

In this section: 2020 | 2019 | 2018 | 2017 | 2016 | 2015 | 2014 | 2013 | 2012 | 2011

2020

Meeting no. Location Date Links
18 Web Conference (hosted by Singapore) 21-25 September 2020 Singapore Virtual Meeting Outcome Statement - PDF (167kb) Singapore Virtual Meeting Outcome Statement - DOCX (84kb) Presentations from IMDRF-DITTA Joint Virtual Workshop (21 September) IMDRF Stakeholder Forum Programme (23 September) - PDF (142kb) IMDRF Presentation - Jurisdictional Update - Australia - PDF (466kb) IMDRF Presentation - Jurisdictional Update - Brazil - PDF (1.02Mb) IMDRF Presentation - Jurisdictional Update - Canada - PDF (172kb) IMDRF Presentation - Jurisdictional Update - China - PDF (169kb) IMDRF Presentation - Jurisdictional Update - EU - PDF (257kb) IMDRF Presentation - Jurisdictional Update - Japan - PDF (571kb) IMDRF Presentation - Jurisdictional Update - Russia - PDF (456kb) IMDRF Presentation - Jurisdictional Update - Singapore - PDF (1.3Mb) IMDRF Presentation - Jurisdictional Update - South Korea - PDF (2.66Mb) IMDRF Presentation - Jurisdictional Update - US - PDF (1.21Mb) IMDRF Presentation - Working Group Update - Regulated Product Submission - PDF (121kb) IMDRF Presentation - Working Group Update - Good Regulatory Review Practice - PDF (375kb) IMDRF Presentation - Working Group Update - Medical Device Adverse Event Terminology - PDF (472kb) IMDRF Presentation - Working Group Update - Personalized Medical Devices - PDF (277kb) IMDRF Presentation - Working Group Update - Medical Device Clinical Evaluation - PDF (726kb) IMDRF Presentation - Working Group Update - Medical Device Cybersecurity Guide - PDF (242kb) IMDRF Presentation - Working Group Update - Principles of In Vitro Diagnostic (IVD) Medical Devices Classification - PDF (526kb) IMDRF Presentation - Working Group Update - Artificial Intelligence Medical Devices - PDF (208kb) IMDRF Presentation - Stakeholder Update - WHO - PDF (596kb) IMDRF Presentation - Stakeholder Update - APEC LSIF RHSC - PDF (171kb) IMDRF Presentation - Stakeholder Update - AHWP - PDF (3.42Mb) IMDRF Presentation - Stakeholder Update - PAHO - PDF (1.52Mb) IMDRF Presentation - Stakeholder Update - DITTA - PDF (2.25Mb) IMDRF Presentation - Stakeholder Update - GMTA - PDF (214kb) IMDRF Presentation - Stakeholder Update - SMF-MTIG - PDF (543Kb) IMDRF Presentation - Stakeholder Update - APACMed - PDF (1Mb)
17 Web Conference (hosted by Singapore) 18 March 2020 Closed session Management Committee meeting outcome statement - PDF (507kb) Closed session Management Committee meeting outcome statement - DOC (114kb)

2019

Meeting no. Location Date Links
16 Yekaterinburg, Russia 16-19 September 2019 Russia Yekaterinburg meeting outcome statement - PDF (139kb) Russia Yekaterinburg meeting outcome statement - DOCX (122kb) Presentation - Medical AI in Skolkovo Global market launch for Russian startups - PDF (2.20Mb) Presentation - Perspectives and Regulatory Considerations for AI based Medical Devices - PDF (1.76Mb) Presentation - World Health Organization plans for using big data and Artificial Intelligence to achieving universal health coverage - PDF (1.07Mb) Presentation - Regulatory framework on medical devices using AI technology in Russia - PDF (791kb) Presentation - The Development of policy measures on medical devices using AI technology in Japan - PDF (725kb) Presentation - Overview of AI Standardization Activities - PDF (1.13Mb) Presentation - Experience of using products based on artificial intelligence in the Yamal Healthcare - PDF (2.02Mb) Presentation - Experience in testing and comparing different solution based on Artificial Intelligence for the Moscow health service - PDF (1.80Mb) Presentation - Preparation and conduct clinical trials for an Artificial Intelligence-based clinical decision support system - PDF (1.63Mb) Presentation - How Industry can cope with challenges - PDF (348kb) Presentation - Industry Responsibility and Liability - PDF (526kb) Presentation - Introduction to review points for decision - making medical device software using deep learning technology - PDF (808KB) Presentation - Regulatory challenges for AI - a European RA perspective - PDF (328kb) Presentation - Industry overview on regulatory challenges - PDF (601kb) Presentation - Applying Advanced Technology in Clinical Practice - PDF (1.31Mb) IMDRF Presentation - Jurisdictional Update - Australia - PDF (326kb) IMDRF Presentation - Jurisdictional Update - Brazil PDF (171kb) IMDRF Presentation - Jurisdictional Update - Canada - PDF (357kb) IMDRF Presentation - Jurisdictional Update - China - PDF (156kb) IMDRF Presentation - Jurisdictional Update - EU - PDF (236kb) IMDRF Presentation - Jurisdictional Update - Japan - PDF (621kb) IMDRF Presentation - Jurisdictional Update - Russia - PDF (832kb) IMDRF Presentation - Jurisdictional Update - Singapore - PDF (174kb) IMDRF Presentation - Jurisdictional Update - South Korea - PDF (2.38Mb) IMDRF Presentation - Jurisdictional Update - USA - PDF (212kb) IMDRF Presentation - Working Group Update - Regulated Products Submission - PDF (116kb) IMDRF Presentation - Working Group Update - Adverse Event Terminology and Coding - PDF (478kb) IMDRF Presentation - Working Group Update - Good Regulatory Review Practices - PDF (380kb) IMDRF Presentation - Working Group Update - Standarts Working Group - PDF (393kb) IMDRF Presentation - Working Group Update - Personalized Medical Devices - PDF (570kb) IMDRF Presentation - Working Group Update - Medical Device Clinical Evaluation - PDF (1.23Mb) IMDRF Presentation - Working Group Update - Medical Device Cybersecurity - PDF (212kb) IMDRF Presentation - Working Group Update - Principles on In Vitro Diagnostic Medical Devices Classification - PDF (728kb) IMDRF Presentation - Stakeholder - Ministry of industry and trade of Russia - PDF (878kb) IMDRF Presentation - Stakeholder - WHO Update - PDF (414kb) IMDRF Presentation - Stakeholder - APEC Update - PDF (178kb) IMDRF Presentation - Stakeholder - AHWP Update - PDF (1.56Mb) IMDRF Presentation - Stakeholder - PAHO Update - PDF (926kb) IMDRF Presentation - Stakeholder - DITTA Update - PDF (512kb) IMDRF Presentation - Stakeholder - GMTA Update - PDF (299kb) IMDRF Presentation - Stakeholder - IAMT Update - PDF (698kb) IMDRF Presentation - Stakeholder - IMEDA Update - PDF (555kb) IMDRF Presentation - Stakeholder - Abbott laboratories Update - PDF (189kb)
15 Moscow, Russia 19-21 March 2019

DITTA/IMDRF joint workshop - Optimizing Standards for Regulatory Use

The IMDRF Standards Working Group and the Global Diagnostic Imaging, Healthcare IT and Radiation Therapy Trade Association (DITTA) held a joint workshop on topics related to the final document: Optimizing Standards for Regulatory Use (IMDRF/Standards WG/N51 FINAL:2018).

The Workshop was held on 18 March 2019 to consider issues from existing projects of the IMDRF Standards Working Group, and interactions with technical committees of the International Standardization Organization (ISO) and International Electrotechnical Commission (IEC). For more details, please go to the 'IMDRF/DITTA workshop' page of the IMDRF 2019 website.

Russia Moscow meeting outcome statement - PDF (146kb) Russia Moscow meeting outcome statement - DOCX (75kb) DITTA Workshop Registration Form Open Stakeholders Day Registration Form Presentation: Improving the quality of international medical device standards for regulatory use - PDF (231kb) Presentation: How the Guidance Supports the Goals of Regulatory Harmonization - PDF (212kb) Presentation: Guidance Structure and Key Proposal - PDF (446kb) Presentation: How standards are used for regulatory purposes among IMDRF members - PDF (673kb) Presentation: Optimized standards to support essential principles of safety and performance of medical devices - PDF (69kb) Presentation: How IEC can contribute to IMDRF to support regulatory convergence - PDF (663kb) Presentation: Test methods in standards requirements and proposals - PDF (929kb) Presentation: How new work items come to be Good standards development practice - PDF (579kb) Presentation: SWG Optimizing Standards for Regulatory Use - PDF (195kb) Presentation: Use of improved Standards from the Russian industry perspective - PDF (660kb) Presentation: Why standards that follow the guidance are good for business - PDF (576kb) Presentation: Future of ISO 13485 and update on ISO 14971 - PDF (474kb) Presentation: The future of the IEC 60601 SERIES - PDF (399kb) Presentation: Optimizing Standards for Regulatory Use_keynote summary - PDF (318kb) Presentation: FDA Overview on NGS Testing - PDF (883kb) Presentation: Next Generation Sequencing - PDF (196kb) Presentation: NGS Dx & EU Regulation - PDF (502kb) Presentation: NGS First Genetics - PDF (725kb) IMDRF Presentation - Jurisdictional Update - Australia - PDF (143kb) IMDRF Presentation - Jurisdictional Update - Brazil - PDF (134kb) IMDRF Presentation - Jurisdictional Update - Canada - PDF (207kb) IMDRF Presentation - Jurisdictional Update - China - PDF (234kb) IMDRF Presentation - Jurisdictional Update - EU - PDF (108kb) IMDRF Presentation - Jurisdictional Update - Japan - PDF (971kb) IMDRF Presentation - Jurisdictional Update - Russia - PDF (396kb) IMDRF Presentation - Jurisdictional Update - Singapore - PDF (265kb) IMDRF Presentation - Jurisdictional Update - South Korea - PDF (583kb) IMDRF Presentation - Jurisdictional Update - US - PDF (421kb) IMDRF Presentation - Stakeholder - AHWP Update - PDF (1.02Mb) IMDRF Presentation - Stakeholder - APEC Update - PDF (91kb) IMDRF Presentation - Stakeholder - DITTA Update - PDF (550kb) IMDRF Presentation - Stakeholder - EAEC Update - PDF (986kb) IMDRF Presentation - Stakeholder - GMTA Update - PDF (204kb) IMDRF Presentation - Stakeholder - IAMT Update - PDF (730kb) IMDRF Presentation - Stakeholder - IMEDA Update - PDF (716kb) IMDRF Presentation - Stakeholder - PAHO Update - PDF (874kb) IMDRF Presentation - Stakeholder - WHO Update - PDF (90kb) IMDRF Presentation - Working Group Update - Adverse Event Terminology - PDF (279kb) IMDRF Presentation - Working Group Update - Good Regulatory Review Practices - PDF (247kb) IMDRF Presentation - Working Group Update - Medical Device Clinical Evaluation - PDF (673kb) IMDRF Presentation - Working Group Update - Medical Device Cybersecurity - PDF (193kb) IMDRF Presentation - Working Group Update - Personolized Medical Devices - PDF (233kb) IMDRF Presentation - Working Group Update - Regulated Products Submission - PDF (88kb) IMDRF Presentation - Working Group Update - Standards - PDF (266kb) IMDRF Presentation - Working Group Update - Unique Device Identification - PDF (137kb)

2018

Meeting no. Location Date Links
14 Beijing, China 18-20 September 2018 China Beijing meeting outcome statement - PDF (125kb) China Beijing meeting outcome statement - DOCX (74kb) Registration page - IMDRF Open Stakeholder Day IMDRF Stakeholder Forum Agenda - PDF (138kb) IMDRF Presentation - Jurisdictional Update - Australia - PDF (531kb) IMDRF Presentation - Jurisdictional Update - Brazil - PDF (133kb) IMDRF Presentation - Jurisdictional Update - Canada - PDF (230kb) IMDRF Presentation - Jurisdictional Update - China - PDF (208kb) IMDRF Presentation - Jurisdictional Update - EU - PDF (96kb) IMDRF Presentation - Jurisdictional Update - Japan - PDF (536kb) IMDRF Presentation - Jurisdictional Update - Russia - PDF (827kb) IMDRF Presentation - Jurisdictional Update - Singapore - PDF (516kb) IMDRF Presentation - Jurisdictional Update - South Korea - PDF (902kb) IMDRF Presentation - Jurisdictional Update - US - PDF (365kb) IMDRF Presentation - Stakeholder - AHWP update - PDF (1.1Mb) IMDRF Presentation - Stakeholder - APEC update - PDF (162kb) IMDRF Presentation - Stakeholder - CAMDI update - PDF (741kb) IMDRF Presentation - Stakeholder - DITTA update - PDF (1.4Mb) IMDRF Presentation - Stakeholder - GMTA update - PDF (282kb) IMDRF Presentation - Stakeholder - Hong Kong SAR update - PDF (1.Mb) IMDRF Presentation - Stakeholder - Mexico COFEPRIS update - PDF (1.3Mb) IMDRF Presentation - Stakeholder - PAHO update - PDF (1Mb) IMDRF Presentation - Stakeholder - WHO update - PDF (247kb) IMDRF Presentation - Working Group Update - Adverse Event Terminology - PDF (697kb) IMDRF Presentation - Working Group Update - Good Regulatory Review Practices - PDF (232kb) IMDRF Presentation - Working Group Update - Medical Device Clinical Evaluation - PDF (214kb) IMDRF Presentation - Working Group Update - Personalized Medical Devices - PDF (650kb) IMDRF Presentation - Working Group Update - Regulated Products Submission - PDF (70kb) IMDRF Presentation - Working Group Update - Standards - PDF (149kb) IMDRF Presentation - Working Group Update - Unique Device Identification - PDF (366kb)
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)

2017

Meeting no. Location Date Links
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)

2016

Meeting no. Location Date Links
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)

2015

Meeting no. Location Date Links
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)

2014

Meeting no. Location Date Links
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)

2013

Meeting no. Location Date Links
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)

2012

Meeting no. Location Date Links
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)

2011

Meeting no. Location Date Links
- Ottawa, Canada 6-7 October 2011 IMDRF Ottawa meeting outcome statement - PDF (52kb) IMDRF Ottawa meeting outcome statement - DOC (63kb)
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