April 2025

Malaysia: MDA Announces Prohibition of Online Sale of Optical Devices and Contact Lenses

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On 25 March 2025, the Medical Device Authority (MDA) of Malaysia issued a press release announcing a prohibition on the online sale of optical devices and contact lenses. These products are designated as prescribed medical devices under the Medical Device Act 2012 (Act 737) and the Opticians Act 1991 (Act 469). Only registered opticians or […]

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Malaysia: Implementation of Medical Device Import Permit 

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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 been designated as the responsible

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Malaysia: MDA Announces Transition to Online Product Classification Application & Implementation of Validity Period for Product Classification Letter

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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 classification applications. The second introduces

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Thailand: (Draft) Criteria, Methods, and Conditions on Labeling and Documentation (IFU) for Medical Devices

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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. Key Summary: Clause 1 This

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Indonesia: Update in the Listing of Healthcare Facilities in the Ministry of Health’s Sectoral Showcase

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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 to the circular, medical device

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Indonesia: Follow-Up Notification on the Electronic Catalogue Transition to Version 6

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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 enhanced Version 6 platform. This

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Philippines: Draft for Comments || Guidelines on the Recall of Authorized Health Products Regulated by the Food and Drug Administration

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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 in the Philippine market. The

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Welcome to Andaman Medical. We are your trusted partner for regulatory affairs and market access in Southeast Asia. 

Whether you are a medical device manufacturer or distributor, our dedicated team is here to help you navigate the complex regulatory landscape and bring your products to market efficiently and compliantly.
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ANDAMAN MEDICAL PTE LTD (Registration no. 201524804D)
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ANDAMAN MEDICAL PTE LTD
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Tampines Junction Business Center Level
09-02, 300 Tampines Avenue 5, Singapore 529653

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