INTERNATIONAL MEDICAL DEVICE REGULATORS FORUM (IMDRF)

About

The IMDRF is a group of medical device regulators from around the world that have voluntarily come together to harmonise the regulatory requirements for medical products that vary from country to country.

It was established in 2011.

Members

Its members include national regulatory authorities of the U.S., Australia, Canada, the European Union, Japan, the United Kingdom, Brazil, Russia, China, South Korea, Singapore and the World Health Organization (WHO).

Observer states 

The World Health Organization (WHO), Argentina, Saudi Arabia, and Switzerland are Official Observers. 

Affiliate Members

IMDRF Affiliate Members include medical device regulatory authorities from Botswana, Chile, Chinese Taipei, Costa Rica, Cuba, Dominican Republic, Egypt, India, Israel, Montenegro, Oman, Paraguay, Peru, South Africa, and Zimbabwe. 

Regional Harmonization Initiatives with IMDRF

The Asia Pacific Economic Cooperation (APEC) Life Sciences Innovation Forum's (LSIF) Regulatory Harmonization Steering Committee, the Global Harmonization Working Party (GHWP), the Pan American Health Organization (PAHO), and the African Medical Devices Forum (AMDF) are Regional Harmonization Initiatives with IMDRF. 

Functions

IMDRF develops internationally agreed-upon documents related to a wide variety of topics affecting medical devices. 

After receiving feedback, IMDRF members adopt these documents and in some cases adapt them to meet the regulatory requirements of their jurisdictions. 

It supports innovation and timely access to new medical devices.

It gives advisories to harmonise the regulatory requirements for medical products.

Significance for India

India’s entry as an associate member will strengthen the Central Drugs Standard Control Organisation (CDSCO’s) medical device regulatory system and help meet emerging technical challenges in India.

PRACTICE QUESTION

Q.Consider the following statements about the “International Medical Device Regulators Forum (IMDRF)” recently seen in the news: 

1. It is an intergovernmental organisation to harmonize the regulatory requirements for medical products that vary from country to country.
2. It supports innovation and timely access to new medical devices.
3. India is a full member of the organisation.

How many of the above statements is/are correct?

A.Only one

B.Only two

C. All Three

D.None

Answer: B

Explanation:

Statement 1 is incorrect: 

The International Medical Device Regulators Forum (IMDRF)  is a group of medical device regulators from around the world that have voluntarily come together to harmonize the regulatory requirements for medical products that vary from country to country.

It was established in 2011.

Statement 2 is correct: 

Its members include national regulatory authorities of the U.S., Australia, Canada, the European Union, Japan, the United Kingdom, Brazil, Russia, China, South Korea, Singapore and the World Health Organization (WHO). 

It supports innovation and timely access to new medical devices.

It gives advisories to harmonize the regulatory requirements for medical products.

Statement 3 is incorrect: 

India has become an affiliate member of the International Medical Device Regulators Forum (IMDRF).