ASEAN Medical Device Regulatory Update

Common Submission Dossier Template

The forthcoming ASEAN Medical Device Directive (AMDD) will cover harmonization for a Common Submission Dossier Template (CSDT) and will govern requirements of product registration. The AMDD is still in its draft form and is being dealt with by the Medical Device Product Working Group (MDPWG) of ASEAN. From the last discussion meeting of the MDPWG, the issue of third party assessment certification has been agreed upon unanimously by the 10 member nations. The regulatory requirement of a CSDT for mandatory implementation in the member nations allows for variation in the recognition of third party assessment bodies.

Asian Harmonization Working Party

The Asian Harmonization Working Party (AHWP) has just begun discussions of third party assessment bodies. As of Nov 2012, it was taken up by the AHWP Workgroup 4 (WG4) – Quality System Audit. There has not been any detailed discussion on the issue yet and therefore so far no specific recommendation for member economies of AHWP to follow or implement yet.

Member Nations of ASEAN

In preparation for the mandatory implementation of the AMDD by mid-2015, some member nations are already implementing AMDD. For example, Malaysia already announced that the Malaysian Medical Device Directive will be made effective July 1, 2013, with a two years grace period. The Malaysian MDD includes detailed requirements for the registration of Conformity Assessment Bodies. Companies will need to complete a fresh application before they can perform the role of a third party assessment body.

However in the Philippines, development has not been transparent.  The Bureau of Health Devices and Technology (BHDT) is responsible for the regulation and product registration of medical devices in Philippines. The BHDT has not announced anything on their website. However, it has been confirmed that letters were sent to all medical device establishments and distributors stating that the existing licenses will expire and new applications are required by  July 1, 2013. The BHDT has not responded to attempts to clarify the new registration requirements. It is highly likely that the enforcement for new registration of medical device establishments such as MRI and CTs, will cause confusion and problems.