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
On December 20, 2024, the Vietnam Ministry of Health (MoH) issued a draft amendment and supplement to several articles of Decree No. 98/2021/ND-CP, dated November 8, 2021, on Medical Devices Management. This draft follows previous amendments introduced by Decree No. 07/2023/ND-CP, dated March 3, 2023. The draft aims to enhance
On December 16, 2024, the Indonesian Ministry of Health issued Notification Letter No. FR.03.01/E.V/2672/2024, classifying Dried Blood Spot as a medical device. This update provides significant regulatory implications for manufacturers, importers, and distributors of the product. Below is a detailed summary of the notification and its key requirements: Details of
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