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Compliance In Focus
Posted by Jacqui Lingler on Wed, May 1, 2013

China Joins the International Medical Device Regulators Forum

China Joins the International Medical Device Regulators ForumThe third meeting of the International Medical Device Regulators Forum (IMDRF), held in France last month, tackled an aggressive agenda to strengthen its role in setting global device policies and added regulators from China for the first time since its inception in October 2011.

The IMDRF is a voluntary group of medical device regulators that aims to accelerate international medical device regulatory harmonization and convergence while coming together to continue the work of the Global Harmonization Task Force (GHTF).  The GHTF, formed in 1992 by European Union, United States, Japanese, Australian, and Canadian medical device regulators was the most successful initiative to harmonize international medical device standards. In November 2012, after publishing dozens of important guidance documents including the GHTF Regulatory Model, the taskforce was disbanded, leaving ongoing projects to the IMDRF.

Brazil and Australia are represented as official members of the IMDRF as well as the World Health Organization serving as an official observer.  The membership of Russian Federation is currently being confirmed.

A limited number of Official Observers can be designated based on the perceived value or contribution to the IMDRF but do not participate in the decision making process.  Other observer groups in attendance at the March meeting include:

  • Mexico
  • Russia
  • Taiwan
  • Singapore
  • Asian Harmonization Working Party

The addition of China to the IMDRF follows just weeks after a Wall Street Journal article announces China’s plan to create a FDA-like body, combining up to 13 different government agencies that regulate food and drug safety. China attempted a similar collaboration in 2003, which failed as a result of a series of corruption scandals.

Lastly, adding to China’s busy month of March, the CFDA released two proposed regulations for medical devices for public comment.  Read IMARC’s blog titled – “China’s Proposed Regulations on Medical Devices-What Should American Device Companies Know?” for further discussion.

Considering the infancy of the CFDA, is their addition to the IMDRF membership beneficial to a collaborative approach to global harmonization? Please feel free to share your comments.

Photo Credit: BWJones

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Topics: World Health Organization, International Medical Device Regulators, China

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