The 12th ASEAN Medical Device Committee (AMDC) Meeting aims to discuss matters, plans and issues that should be implemented within the AMDC to ensure that the ASEAN Medical Device Directive (AMDD) agreement is complied with and discuss the needs, technical exercises and capacity building for AMDC as well as its dialogue partners, such as the United States and Japan.
The meeting, held at the Radisson Hotel, kicked off yesterday and will conclude tomorrow.
The meeting will also discuss harmonised technical and guidance documents that will be adopted by ASEAN member states.
Among the attendees are representatives of the Department of Healthcare Technology at the Ministry of Health as well as medical device regulatory authorities in ASEAN member states.
The AMDC was established following the signing of the ASEAN Medical Device Directive (AMDD) agreement by the ASEAN Trade Ministers on November 21, 2014.
It is a product working group (PWG) in standards and conformance, organised by the ASEAN Consultative Committee on Standards and Quality (ACCSQ), which is a working committee of the ASEAN Economic Community (AEC).
The first AMDC meeting was held in Kuala Lumpur, Malaysia in December 2015. Prior to its establishment, the PWG for medical devices products under the ACCSQ was the Medical Device Product Working Group (MDPWG), responsible for discussing AMDD.
The purpose of the AMDC is to monitor the implementation of the AMDD agreement in ASEAN member states and provide assistance to member countries in need.
It also ensures a uniform interpretation of the AMDD agreement by ASEAN member states, to ensure that the AMDD can be implemented in an orderly manner to support the goals of the AEC by drafting work plans and technical assistance, such as capacity development programmes as well as training.
It also assists ASEAN member countries with medical equipment, including planning, training and capacity building with dialogue partners. – Azlan Othman
