Malaysia – Singapore Medical Device Reliance

The Medical Device Authority (MDA) of Malaysia and the Health Sciences Authority (HSA) of Singapore signed a Memorandum of Understanding (MoU) during the 14th ASEAN Medical Device Committee (AMDC) Meeting held in Siem Reap, Cambodia on 22 August 2025. The authorities also jointly launched a 6-month pilot of the Medical Device Regulatory Reliance Programme which will run from 1 September 2025 to 28 February 2026, as part of the MoU.

This regulatory cooperation under the Malaysia-Singapore Medical Device Regulatory Reliance Programme is designed to facilitate a streamlined registration process of medical devices between both countries, and for Class B, C and D medical devices.

The pilot phase of the 6-month Medical Device Regulatory Reliance Programme will focus on optimising regulatory processes and coordination mechanisms while assessing the effectiveness of the programme.

Medical Device Registration Certificate Holders participating in the pilot can expect reduced review times for medical device registration in both countries:

In Malaysia: Devices registered with HSA may undergo a verification route (abridged review pathway) through MDA's Conformity Assessment Body (CAB). The review is expected to take 30 working days, compared to 60 working days under the full conformity assessment route. The device will then be registered within 30 working days.

In Singapore: Devices registered with MDA will benefit from an abridged review pathway, achieving up to 30% shorter review times across all Class B to D medical devices.