On 26 March 2025, the Medical Device Authority (MDA) of Malaysia officially announced the implementation of a Medical Device Import Permit (IP) requirement under the Customs (Prohibition of Import) Order 2023. This new regulation mandates that importers obtain an Import Permit for bringing medical devices into Malaysia. The MDA has
On April 8, 2025, the Medical Device Authority (MDA) of Malaysia released two important regulatory updates to enhance efficiency, strengthen compliance, and improve the overall submission process for product classification. These updates are effective starting May 1, 2025. The first update mandates the full transition to online submission for product
On March 18, 2025, the Ministry of Public Health (MoPH) of Thailand released a draft notification to amend its 2020 regulation on the criteria, methods, and conditions for labeling and documentation of medical devices (B.E. 2563), in alignment with the Medical Device Act B.E. 2551 (2008) and its 2019 amendment.
On March 21, 2025, the Ministry of Health announced an update regarding the listing of healthcare facilities in the Sectoral Showcase of the Electronic Catalogue Version 5. This follows the issuance of Circular Letter Number 6432/KA/03/2025, which outlines the transition process for medical device commodities in the procurement system. According
On March 20, 2025, the Indonesian government issued a follow-up notification in accordance with Circular Letter No. 9 of 2024 regarding the transition from Electronic Catalogue Version 5 to Version 6. The updated guidance outlines the deactivation of certain commodities from Version 5 and introduces a phased migration to the
On March 31, 2025, the Food and Drug Administration (FDA) of the Philippines released a draft circular titled “Guidelines on the Recall of Authorized Health Products Regulated by the Food and Drug Administration”. The draft circular aims to establish effective recall procedures for authorized health products regulated by the FDA
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