Whatever happened to the ASEAN medical device directive?
By Stewart Eisenhart, Emergo Group Back in 2012 and 2013, Emergo and other medical device industry news sources began reporting on an effort by the Association of Southeast Asian Nations (ASEAN) trade bloc to establish harmonized device registration systems across 10 countries in the region. Now, while a few member countries have made significant progress toward realizing that effort, the ASEAN Medical Device Directive (AMDD) as a whole remains a work in progress. According to the AMDD agreement as drafted, uniform (or at least highly similar) requirements for device registration, quality system compliance and related issues were to be agreed upon by 2015 in 10 countries: Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand and Vietnam. Although the AMDD would not create a single, 10-member market a la Europe, where a medical device certified for sale in one member state may be sold in all others, the Directive would make it significantly easier for a manufacturer that registers a device for sale in, say, Singapore to then apply for registration in another ASEAN member country such as Malaysia or Indonesia. As of 2015, governments of all 10 countries listed above have signed on to implement the AMDD, but some countries (Singapore and Malaysia in particular) are much further ahead in terms of actual implementation of policies and practices based on the AMDD than others. Next steps? ASEAN officials provided an update on AMDD implementation...
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