Malaysia has been proposed as the coordinating entry point for the first stage of an ASEAN-wide system for medical device applications. The plan would allow manufacturers to submit technical documents through a common channel before the files are distributed to participating regulators. Health Minister Datuk Seri Dr Dzulkefly Ahmad said ASEAN member states supported Malaysia's proposed role during the first ASEAN Roundtable on Medical Devices.

The meeting was organised by Malaysia's Medical Device Authority and chaired by Dzulkefly. It brought together health ministers and delegates from Brunei, Cambodia, Indonesia, Laos, Myanmar, the Philippines, Thailand, Timor-Leste and Vietnam. Participants agreed in principle to develop the single-submission system in stages, with Malaysia receiving and coordinating the distribution of technical dossiers during the initial period.

The proposed arrangement is intended to reduce repeated administrative work when companies seek approval for the same product in several ASEAN markets. Each national authority would still make its own final decision and register devices under its domestic laws, so the model would not remove national control. The common entry point would instead make the early submission process more organised and could help regulators exchange information more efficiently.

The ASEAN Medical Device Committee and the ASEAN Secretariat will now work on an implementation mechanism. Their preparations are expected to continue ahead of the committee's meeting in Vientiane, Laos, from October 6 to 8. Dzulkefly said the initiative could strengthen patient safety while supporting faster and fairer access to quality medical devices across the region.