The ASEAN Consultative Committee for Standards and Quality was formed by the ASEAN Economic Minister in 1992 with the aim of removing technical barriers to trades in order to facilitate the implementation of the Common Effective Preferential Tariff (CEPT) Agreement to realize the ASEAN Free Trade Area (AFTA).

At the 4th Senior Economic Officials Meeting (SEOM) held in Medan , Indonesia on 8-10 September 1997, the SEOM authorized ACCSQ to involve regulatory bodies in order to achieve its mandate of eliminating technical barrier to trade. During the 24th ACCSQ Meeting on 3rd to 4th August 2004, the formation of a Product Working Group on Medical Device (ACCSQ-MDPWG) was proposed to implement specific measures on medical device under the roadmap for healthcare integration. This is to be in-line with the decision of the ASEAN Leaders on the establishment of the ASEAN Economic Community (AEC) by the year 2020 and fast- track integration of the eleven priority sectors including healthcare sector. The ACCSQ-MDPWG proposal was approved by the SEOM I/36 held on 17-19 January 2005 in Yogyakarta , Indonesia.