Skip to main content
A Singapore Government Agency Website

International Medical Device Regulators Forum (IMDRF)

Find out about the collaborations with the International Medical Device Regulators Forum (IMDRF).

About the IMDRF

The IMDRF comprises a group of regulators that come together to drive medical device regulatory harmonisation and convergence. The IMDRF Management Committee, composed of regulatory officials, provides guidance on strategies, policies, directions, membership and activities of the Forum.

The current Management Committee members consist of regulatory agencies from Australia, Brazil, Canada, China, European Union, Japan, Russia, Singapore, South Korea, and the United States of America.

For more information on the IMDRF, please refer to the IMDRF website.

Meetings

HSA has assumed chairmanship for IMDRF in 2020 to drive strategic directions and facilitate collaborations amongst the IMDRF regulators and stakeholder groups.

The following meetings were held:

 

IMDRF Stakeholders Forum
Via Zoom Webinar, 23 September 2020, 6.00pm Singapore Time

Join the international medical device regulators and leading industry partners at this Webinar to exchange perspectives and gain insights on:

  • Regulatory updates by the IMDRF Management Committee
  • Progress and plans for the IMDRF Work Items
  • Global trends on medical device development

Participants are encouraged to go through the presentation materials and submit your questions via the Submission Form below by 9 September 2020.

Please note that all questions will be moderated. Due to limited duration of the webinar, only questions which are submitted via the form before the closing date will be prioritised for consideration.

Programme206 KB

Register for the Webinar (Closed)

Questions Submission Form (Closed)

Presentation Materials for Pre-Reading *Updated 23 September 2020*

Segment 1: Regulatory Updates by IMDRF Management Committee

1a. Australia

Download 

1b. Brazil (voice annotated)

View online
Download

1c. Canada

Download 

1d. China

Download 

1e. European Union

Download          

1f. Japan (voice annotated)

View online
Download

1g. Russia

Download             

1h. Singapore (voice annotated)

View online
Download

1i. South Korea (voice annotated)

View Online
Download

1j. United States

Download

Segment 2: Progress of IMDRF Work Items

2a. Regulated Product Submission

Download

2b. Good Regulatory Review Practice
(voice annotated)

View Online
Download

2c. Medical Device Adverse Event
Terminology (voice annotated)

View Online
Download

2d. Personalized Medical Devices

Download

2e. Medical Device Clinical Evaluation

Download 

2f. Medical Device Cybersecurity Guide

Download 

2g. Principles of In Vitro Diagnostic (IVD)
Medical Devices Classification

Download 

2h. Artificial Intelligence Medical Devices

Download 

Segment 3: Stakeholders Session

3a. WHO (Official Observer)

Download

3b. APEC LSIF RHSC (Regional Harmonisation Initiative)

Download

3c. AHWP (Regional Harmonisation Initiative)

Download

3d. PAHO (Regional Harmonisation Initiative)

Download

3e. DITTA (Industry)

Download

3f. GMTA (Industry)

Download 

3g. SMF MTIG (Industry)

Download

3h. APACMed (Industry)

Download
Share