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Regulatory Focus™ > News Articles > Asian Harmonization Working Party Joins ISO, IMDRF

Asian Harmonization Working Party Joins ISO, IMDRF

Posted 01 May 2012 | By Alexander Gaffney, RAC 

The Asian Harmonization Working Party (AHWP) has announced it has been accepted as a member in both the International Medical Devices Regulators Forum (IMDRF) and the International Standards Organization (ISO).

AHWP is a non-profit dedicated to the harmonization of medical device regulations, and includes among its members China, India, Saudi Arabia, Korea, South Africa and Pakistan.

The organization said IMDRF had extended an invitation for AHWP to join its Forum as an affiliated organization and to act as an official observer on its Management Committee, which it accepted on 30 April.

"We look forward to working with IMDRF to enhance medical devices regulatory harmonization, accelerate international convergence, and achieve alignments of IMDRF and AHWP harmonization efforts," said AHWP in a statement posted on its website.

The group also announced its petition to join ISO's Technical Committee 210, ISO's quality management committee for medical devices, had been accepted. AHWP said in a statement it looked forward to assisting ISO on the "standardization of requirements and guidance in the field of quality management."

Read more:

AHWP's Participation in ISO / TC 210

AHWP's Participation in the International Medical Device Regulators Forum (IMDRF)


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