Playbook for Implementation of a Medical Device Regulatory Framework
(2014; 47 pages)

Abstract

In line with the goal of the Asian Harmonization Working Party (AHWP) to study and recommend ways to harmonize medical device regulations in the Asian and other regions, the AHWP Technical Committee (AHWP 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.

It is important to recognize the necessity of a regulatory framework for medical devices and the benefits international convergence of controls may have to facilitate market access and reduce regulatory burden. However, while member economies are familiar with “why” regulatory controls are necessary, the question of “how”– how such recommended controls may be implemented - has been less frequently addressed. Given the cultural and socio-economic variations across member economies, implementation processes will inevitably vary and no single set of implementation plans prescribed can effectively address the needs of each country.

Nevertheless, a general set of guidelines for consideration can be provided to member economies to facilitate this process, along with the collation of existing tools, developed by the collective experience and expertise of various other international organizations, for the member economy’s reference.

With the efforts of the AHWP TC in line with the goal of the AHWP, 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.

 
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