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Malaysia: MDA Reminder on Online Selling of Medical Devices

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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 1. Requirement for Registration and […]

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Indonesia: Temporary Closure of Online Licensing and Certification Systems for Medical Devices

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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 health sub-sector. To read

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Indonesia: Update on Medical Device Curation Progress for National Electronic e-Catalogue Version 6

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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] (Provided in Indonesian; English translation

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Malaysia and China Establish Medical Device Regulatory Reliance Programme

Malaysia and China Establish Medical Device Regulatory Reliance Programme To Reduce Approval Timelines

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On July 16, 2025, the Ministry of Health Malaysia announced the launch of the Medical Device Regulatory Reliance Programme with China. This landmark initiative, revealed during the HIMSS Asia-Pacific Health Conference & Exhibition 2025 in Kuala Lumpur, marks a strategic breakthrough in accelerating patient access to safe and innovative medical technologies.  The programme builds on

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Indonesia: Extension of Product Registration Deadline for Ministry of Health’s e-Catalogue

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The National Public Procurement Agency (LKPP: Lembaga Kebijakan Pengadaan Barang/Jasa Pemerintah) under Indonesia’s Ministry of Health has extended the product registration deadline for the e-Catalogue procurement process until March 20, 2025. The e-Catalogue serves as an official government procurement platform for medical device products. Key Update Stakeholders can continue to list their medical devices in

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Malaysia: Issuance of Second Edition Guidance on HIV Self-Test Kit (HIVST) Placement

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On January 31, 2025, the Medical Device Authority (MDA) of Malaysia released the Second Edition Guidance Document (MDA/GD/0065) on the placement of HIV Self-Test Kits (HIVST) in the Malaysian market. This updated guidance document introduces several key revisions affecting regulatory requirements, performance evaluation, conformity assessment, registration, labeling, and post-market surveillance. Key Updates in the Second

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Thailand: Priority Track Supporting Policies for Medical Device Registration to Reduce Chronic Diseases

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On January 22, 2025, the Medical Device Control Division (MDCD) of Thailand released an infographic outlining the Priority Track for medical device registration. This initiative aims to expedite the approval process for medical devices that contribute to the prevention and management of chronic diseases, including diabetes, hypertension, hyperlipidemia, cardiovascular diseases, and cancer. Eligible Medical Devices

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Indonesia: Dermal Filler Classified as a Medical Device

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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 under the General Surgical Equipment

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Vietnam: MoH Issues Notice on Medical Devices with Import Licenses Expiring December 31, 2024

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On December 9, 2024, the Vietnam Ministry of Health (MoH) issued Official Dispatch No. 7614/BYT-HTTB, addressing the supply of medical devices whose import licenses will expire on December 31, 2024. This notice outlines measures to ensure an uninterrupted supply of medical devices while emphasizing compliance with regulatory requirements. Key Actions for Medical Device Importers Devices

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Vietnam: MoH Abolishes Regulations on Manufacturer’s Codes and Medical Supplies Encoding

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On November 21, 2024, the Vietnam Ministry of Health (MoH) issued Decision No. 3514/QD-BYT, officially abolishing Decision No. 5086/QD-BYT and Decision No. 2807/QD-BYT. These decisions previously governed the list of manufacturer’s codes and the encoding of medical supplies for health insurance and healthcare expenses. Updated Guidelines for Medical Supplies Codes The new decision introduces the

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Vietnam: MoH Promulgates List of Medical Devices with Assigned Harmonized System Codes

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In October 2024, the Ministry of Health (MoH) of Vietnam issued Circular 19/2024/TT-BYT, which promulgates the list of medical devices assigned Harmonized System (HS) codes. This update follows Circular 31/2022/BTC on Vietnam’s nomenclature of exports and imports. The new circular takes effect from November 16, 2024, and replaces the previous Circular 14/2018/TT-BYT, dated May 15,

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Thailand: Clarification on Vehicles and Medical Equipment Products as Medical Devices

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On November 22, 2024, the Thai FDA published an infographic on its official website, providing clarity on the classification of vehicles and medical equipment as medical devices under Thailand’s Medical Device Acts. Vehicles: Not Classified as Medical Devices The infographic specifies that the following vehicles are not considered medical devices under Section 4 of the

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Indonesia: Important Requirement for IDAK (Medical Device Distributor License) Holder

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On October 30, 2024, the Director of Medical Device Production and Distribution in Indonesia issued Notification Letter No. FR.03.06/E.V/1905/2024, outlining new requirements for fulfilling the Medical Device Distributor License (IDAK). This letter introduces key conditions that distributors must meet to maintain compliance under the new regulations. You can access the official notification letter in Indonesian

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Indonesia: Implementation of Halal Product Assurance for Medical Devices Circulating in Indonesia

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The Government of Indonesia has introduced Government Regulation No. 42 of 2024 on Halal Product Assurance, enhancing and expanding on the prior Government Regulation No. 39 of 2021. This regulation aims to provide legal certainty and assurance to the public regarding the halal status of products available within Indonesia. All products that are circulated, supplied,

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Thailand: Guidelines for Determining Health-Type Software Products

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The Thai Food and Drug Administration (FDA) has reissued Guidelines for Determining Health-Type Software Products to help medical device registrants obtain accurate classification information. These guidelines provide clarity on which software products qualify as medical devices under Thai law, aiding stakeholders such as manufacturers, importers, and public health agencies in regulatory compliance. Types of Health-Type

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Andaman Medical: A Partner in Bio Preventive Medicine Corporation’s Expansion

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Bio Preventive Medicine Corporation (BPM) is a leading biotech company specialising in renal biomarkers. With a focus on translating validated and IP-protected novel biomarkers into diagnostic solutions for unmet clinical needs, BPM has developed innovative products that are revolutionising the field of kidney disease diagnosis and management. One such product is the DNlite-IVD103, a non-invasive

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