The global economic crisis of 2008 has strengthened the position of medical device Asian manufacturers who can offer quality products lower prices. Quality is presented by compliance with the international regulatory standards such as the US FDA and the EU CE mark.  This has opened western markets for the South East Asian device manufacturers.

A strong trend towards increased regulation can be observed in most of the countries in this region. Regulation harmonization is also underway, which is being lead by the Association of Southeast Asian Nations (ASEAN). The ASEAN - Consultative Committee for Standards and Quality and its dedicated Medical Device Program Working Group (ACCSQ-MDPWG) are involved.

As of 2010, ASEAN member states are Brunei, Myanmar, Cambodia, Indonesia, Laos, Malaysia, Philippines, Singapore, Thailand and Vietnam. There is one candidate member state and one observer state.