Background & Objectives

Introduction to AHWP TC Workgroup - WG01

Background
 

Efforts toward harmonization of medical device regulation were initiated amongst membereconomies in the Asian Pacific region with the formal formation of AHWP in 2000. At the 9th AHWP Regional Meeting of 14 May 2002 (Singapore), member economies identified two initiatives for regional collaboration, namely, to explore common harmonized approaches to;


1.Quality System and Audit

2.Pre-market Submission Requirements and STED (Summary technical documentation for demonstrating conformity to essential principles of safety and performance of medical devices).


At the 2 nd AHWP Technical Committee (TC) Meeting of 12-13 December 2002 (Bangkok), there was general consensus agreement amongst member economies to lay out a preparatory work plan for a common approach to submission requirements in the application to place medical devices on the Asian markets. A pre-market submission survey of member economies showed that more than 70% of the STED elements were used by member economies with marketing clearance requirements for medical devices. At the 3rd AHWP TC Meeting of 29-30 April 2004 (Taipei), seven member economies indicated interest to lead in the development of a common pre-market submission dossier as a collaborative regional harmonization project.

Objectives

The TC Working Group's objective is to work out an acceptable format suitable for the preparation and submission of a well-structured dossier for the purpose of seeking marketing authorization of medical devices in Asian markets within the AHWP member economies.

Details of the scope of the collaborative project and the terms of reference for the Working Group WG01 are found in the project proposal. The general scopes of the project are:

-Define an Action Plan and Work Items for the Working Group Work out an acceptable format for the preparation and submission of a well-structure dossier

-Review and define the pre-market submission requirements and provide guidance to support submissions

-Review and recommend appropriate training and capacity building for member economies

-Recommend to AHWP the adoption of the common pre-market submission dossier