Nov 8, 2012

The Asian Harmonization Working Party (AHWP), a group of medical device regulatory authorities and industry participants from 23 countries worldwide, has issued a strategic framework (PDF) to develop more uniform and harmonized regulatory structures for medical device markets in Asia.

The proposal consists of five broad elements that the AHWP aims to see implemented across members’ markets by 2020; elements include expanded membership, training and capacity building among members, and harmonization of medical device registration requirements in regional and global markets according to Global Harmonization Task Force (GHTF) principles.

In addition, the AHWP framework targets greater coordination with the APEC Regulatory Convergence for Medical Products, which pushes greater regulatory convergence among APEC members by 2020, and the ASEAN Medical Device Directive (AMDD), which would establish a single medical device regulatory community among ASEAN member states by 2015.

The final element of the framework entails expanding AHWP’s partnerships with other industry and regulatory entities in order to advance the organization’s regional harmonization goals.

Bottom line: the more harmonization advocates, for Asian or any markets, the better—in terms of both improved patient safety standards as well as clear and efficient regulatory processes for industry.


  • Stewart Eisenhart