ABSTRACT
I am honored to write on behalf of the Asian Harmonization Work Party (AHWP) an introductory note to the Handbook of Medical Device Regulatory Affairs in Asia, as part of the Asia Regulatory Professional Association (ARPA) initiative.This handbook is in line with Asian Harmonization Working Party scope and objectives to harmonize Medical Device Regulation among member economies. The AHWP is a nonprofit organization that was formed by a group of regulators in Asia Pacific around 1996-1997. It aims to develop techniques to harmonize medical device regulations in Asia and other regions, to work in coordination with the Global Harmonization Task Force (GHTF), Asia-Pacific Economic Cooperation (APEC), and other related international organizations aiming at establishing harmonized requirements, procedures, and standards.
