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 progress at a meeting of the 20^th Asian Harmonization Working Party (AHWP) Annual Meeting in November 2015. There, ASEAN identified some of the heavy lifting still to be accomplished in order to establish the AMDD as a functioning regulatory framework.

Chief among these steps is transposing the AMDD into national legislation consistent across all 10 member countries. Again, governments in Singapore and Malaysia have reported significant progress in this area, but their regional partners have some serious catching up to do.

In 2016, ASEAN members will focus their efforts on developing a Work Plan on Implementation of AMDD, with Singapore’s Health Sciences Authority taking the lead on that initiative. The scope of the work plan will include developing common nomenclature, post-market surveillance guidelines and device grouping guidance. Singaporean regulators have already deployed AMDD-compliant processes to address these issues.

As to the question of when, ASEAN has yet to divulge any timeframes regarding implementation milestones. Emergo consultants in Singapore and Kuala Lumpur will continue assessing AMDD implementation progress across Southeast Asia, and we’ll accordingly report any news.

Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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