The Medical Device Authority (MDA) of Malaysia hosted a Facebook Live event on January 14, 2025, titled “Chief Executive New Year Message: What’s Beyond 2025”. Delivered by the MDA Chief Executive, the session highlighted key regulatory and developmental plans for the coming years. Key Highlights from the Facebook Live Event
On January 1, 2025, the Republic of Indonesia will officially implement Electronic Catalogue Version 6 for the procurement of goods and services, in accordance with a directive from the President of the Republic of Indonesia. As part of this transition, Electronic Catalogue Version 5 will be deactivated on December 31,
The Health Sciences Authority (HSA) of Singapore has issued a new guidance document, “GN-37-R1 Change Management Program (CMP) for SaMD, including machine-learning enabled SaMD,” which became effective on 4th December 2024. Key Highlights of GN-37-R1 Introduction of the Change Management Program (CMP) The CMP provides a framework for “pre-specified changes”
On December 4, 2024, the Thai FDA announced revisions to the regulations governing medical device advertising. These updates, outlined in the “Food and Drug Administration Announcement RE: Determination of Criteria, Conditions, and Requirements for Approval, Issuance of License, and License Validity for Medical Device Advertising B.E. 2568 (2025)”, aim to
The Ministry of Health (MoH) of Indonesia has announced an update regarding the listing of medical device products in the e-Catalogue managed by the National Public Procurement Agency (LKPP: Lembaga Kebijakan Pengadaan Barang/Jasa Pemerintah). This update affects stakeholders who sell their medical device products through the government purchasing system. Extended
On December 19, 2024, the Indonesian Ministry of Health issued Letter No. FR.03.01/E.V/2728/2024, officially classifying dermal fillers as medical devices. This announcement provides guidance to facilitate the importation of dermal fillers into Indonesia while ensuring compliance with regulatory requirements: Classification of Dermal Fillers Dermal fillers are categorized as medical devices
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