Medical Devices

Date of establishment: 11 October 2012

Purpose: To support MOH in developing regulations on medical device management and to share about integration regulations on medical device management with TWG members.

Objectives: (i) To build a legal and policy forum on medical devices; (ii) To coordinate and support the MOH in analyzing, evaluating and providing recommendations on medical device management; (iii) To coordinate and support the MOH in developing and implementing policies and regulations on medical service management, step by step integrating with regional and international environment.

Structure: The TWG on Medical Devices (MDG) is chaired by the Department of Medical Device Management with participation of DPs mostly from multi-national corporations. WHO provides technical support to the group.

Meeting frequency: This TWG has not been active, but has contributed to the development of legal documents on medical device management, such as Circulars and Decrees on medical device classification; Decree on Medical Device management which is expected to be issued by end of 2015; Decree on Medical Device management for ASEAN in 2014.

Contribution: This TWG has not been active, but has contributed to the development of legal documents on medical device management, such as Circulars and Decrees on medical device classification; Decree on Medical Device management which is expected to be issued by end of 2015; Decree on Medical Device management for ASEAN in 2014.

Relevant documents:

• MDG Meeting minutes/ Reports

• MDG TOR