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
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
The Ministry of Health of the Republic of Indonesia has announced the temporary closing of the Online Medical Device Licensing System (Regalkes) and the Online Certification System (e-SUKA). This measure is carried out in accordance with Minister of Health Regulation No. 11 of 2025 concerning business and product/service standards within
The Ministry of Health of the Republic of Indonesia has issued an official notification providing an update on the progress of the medical device curation process for inclusion in the National Electronic e-Catalogue Version 6 (“the e-Catalogue”). To read the full notification: Ministry of Health Notification Letter No. BJ.02.03/A.VI/8790/2025 [pdf]
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
The Ministry of Health of the Republic of Indonesia has issued Regulation of the Minister of Health No. 11 of 2025 (“the Regulation”) concerning Business and Product/Service Standards for Risk-Based Licensing in the Health Sub-sector. The Regulation comprises 40 articles and 1 appendix and introduces updated requirements for licensing within
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