Asian Harmonization Working Party (AHWP)

The Asian Harmonization Working Party (AHWP) was established in 1996 as a non-profit organization by a group of medical device regulatory authorities and the medical device industry.

It aims to promote harmonization among its member economies through the adoption and application of GHTF guidance documents in collaboration with the Asia Pacific Economic Cooperation (APEC) and the Association of East Asian Nations (ASEAN) and other related international organizations. AHWP is a platform for the harmonization of medical device regulations among member economies to ensure safety, quality, and effectiveness of medical devices marketed in its member economies.

Membership is open to representatives from Asia and other regions that support the above stated goals. Current AHWP members include Abu Dhabi, Brunei Darussalam, Cambodia, Chile, Chinese Taipei, Hong Kong SAR, China, India, Indonesia, Jordan, Kingdom of Saudi Arabia, Korea, Laos PDR, Malaysia, Myanmar, Pakistan, People's Republic of China, Philippines, People's Republic of China, Singapore, South Africa, Thailand, Vietnam and Yemen.

Seven AHWP working groups have been established including Working Group 1a that specifically address issues related to IVDDs:

Work Group 1 (WG1) - Pre-Market Submission and Common Submission Dossier Template (CSDT)

Work Group 1a (WG1a) - IVDD

Work Group 2 (WG2) - Post-Market Surveillance and Vigilance

Work Group 3 (WG3) - Quality Management System

Work Group 4 (WG4) - Quality System Audit

Work Group 5 (WG5) - Clinical Safety/Performance

Work Group 6 (WG6) - Capacity Building and Regulatory Training

Work Group 7 (WG7) - Standards

Special Task Group (STG - Nomenclature) - Medical Device Nomenclature

More information can be found on the AHWP website.

Contact us

The International Diagnostics Centre
London School of Hygiene & Tropical Medicine
Keppel St
United Kingdom
admin [at] idc-dx [dot] org