• 2026-05-22 06:47:10

The Medical Device Authority (MDA) of Malaysia and the Thailand Food and Drug Administration (Thai FDA) have officially announced the successful completion of a three-month pilot phase, which took place from 1 February 2026 to 30 April 2026. Following this pilot phase, the full implementation of the MDA–Thai FDA Medical Device Regulatory Reliance Programme will now apply to the registration of Class B, Class C, and Class D medical devices.

• 2025-09-24 08:22:59

The Medica Device Authority (MDA) of Malaysia and the Health Sciences Authority (HSA) of Singapore officially launched a 6-month pilot of the Medical Device Regulatory Reliance Programme to streamline approvals for Class B–D devices. The main purpose are to fast-track market access, cutting cost, reducing duplication and enhanced patient care.

• 2025-08-25 03:35:27

The Ministry of Health Malaysia (MOH) has announced an international regulatory collaboration with China National Medical Products Administration (NMPA). This collaboration aims for accelerate pre-market approvals, quicker market access, reduced costs and enhanced patient care while strengthens Malaysia's role as regional regulatory hub.

• 2024-05-07 08:47:38

Thai FDA has replaced its previous criteria for evaluating medical devices via expedited routes with new guidelines published in 2024. The aim is to streamline the evaluation process for Licensed and Notified medical devices (Class 2,3,4) while ensuring quality, efficiency, and safety. The announcement outlines criteria, documents required, and regulatory procedures for the Concise Evaluation and Reliance Program routes under expedited route review.