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 […]
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
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
Malaysia: Issuance of Second Edition Guidance on HIV Self-Test Kit (HIVST) Placement Read More »
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
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
Indonesia: Dermal Filler Classified as a Medical Device Read More »
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
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
Vietnam: MoH Abolishes Regulations on Manufacturer’s Codes and Medical Supplies Encoding Read More »
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,
Vietnam: MoH Promulgates List of Medical Devices with Assigned Harmonized System Codes Read More »
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
Thailand: Clarification on Vehicles and Medical Equipment Products as Medical Devices Read More »
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
Indonesia: Important Requirement for IDAK (Medical Device Distributor License) Holder Read More »
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,
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
Thailand: Guidelines for Determining Health-Type Software Products Read More »
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
Andaman Medical: A Partner in Bio Preventive Medicine Corporation’s Expansion Read More »
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