TC Playbook

In line with the goal of the Global Harmonization Working Party (GHWP) to study and recommend ways to harmonize medical device regulations in the Asian and other regions, the GHWP Technical Committee (GHWP TC) as the executive arm of the Party has worked over the years to develop technical documents and policy papers in recommendation of regulatory best practices to member economies.

With the efforts of the GHWP TC in line with the goal of the GHWP, this playbook was developed to provide the guidelines and referenced tools needed to bridge this gap, to guide member economies in development of their medical device regulatory framework.