November 2025

The Medical Device Authority (MDA) of Malaysia has issued an announcement regarding the implementation of a validity period for the Product Classification Letter, effectively revoking the previous announcement dated 1 April 2025. To read the full announcement: Implementation of Validity Period for Product Classification Letter [link] Key Updates 1. Introduction of Validity Period As stated

The Medical Device Authority (MDA) of Malaysia has issued a media statement reminding all stakeholders of their responsibilities concerning the online sale, advertising, and distribution of medical devices under the Medical Devices Act 2012 (Act 737). To read the full announcement: MDA Reminder on Registered Medical Devices [link] Key Updates 1. Requirement for Registration and

The Medical Device Authority (MDA) of Malaysia has announced the successful conclusion of the Malaysia–United States Agreement on Reciprocal Trade, marking a landmark achievement for the nation’s medical device industry. The announcement coincides with the ASEAN Summit 2025, underscoring Malaysia’s commitment to advancing international trade and regulatory cooperation in the healthcare sector. Scope Summary of

The Medical Device Authority (MDA), in collaboration with the Universiti Malaya (UM) research team, is conducting a study titled “Barriers, Risks, and Regulations in Malaysia’s Medical Device Industry”. Scope Summary of the online survey conducted jointly by the Medical Device Authority (MDA) and Universiti Malaya (UM) to identify barriers, risks, and opportunities within Malaysia’s medical