The Medical Device Authority (MDA) has announced the approval of a minor amendment to Circular Letter No. 1 Year 2025. The revised document is now designated as Circular Letter No. 2 Year 2025 (“the Circular”) and took effect on 30 September 2025. Scope Summary of the latest update issued by the Medical Device Authority […]
The Medical Device Authority (MDA) has released the draft Seventh Edition of the Guidance Document titled “Requirements for Labelling of Medical Devices” for public consultation. The draft introduces key amendments to the existing labelling framework, including the proposed implementation of electronic labelling (e-labelling) for home-use medical devices, aligning Malaysia’s regulatory approach with international best practices.
Malaysia: Requirements for Labelling of Medical Devices Read More »
The Medical Device Authority (MDA) has published the draft First Edition Guidance Document (PDF) titled “Application for Confirmation Status of Obsolete and Discontinued Medical Device” for public comment. The guidance outlines the eligibility criteria, application procedures, and the responsibilities and obligations of establishments in managing obsolete and discontinued medical devices. To access the guidance document
The medtech landscape across Asia-Pacific continues to evolve rapidly, shaped by shifting regulatory frameworks, economic transitions, and an increased focus on localization, digital health, and market access complexity. Companies operating in the region must adapt quickly to maintain competitiveness, particularly in Southeast Asia’s high-growth healthcare markets. Localisation and Government Push for Onshore Manufacturing Governments across
Medtech Outlook: Navigating Asia-Pacific in 2026 Read More »
The Health Sciences Authority (HSA) and the Singapore Manufacturing Federation (SMF), through its Medical Technology Industry Group (MTIG), have launched an integrated regulatory support ecosystem for Singapore’s MedTech sector. This collaboration combines the SME Centre@SMF’s business advisory services with HSA’s Health Products Regulation Group (HPRG) Innovation Office to shift regulatory processes from reactive compliance to
Singapore: HSA–SMF Partnership Enhances MedTech Regulatory Support and Market Access Read More »
The Food and Drug Administration (FDA) of the Philippines has released a draft Circular titled “Guidelines on the Inspection of Medical Device Establishments” to enhance regulatory oversight and ensure continued compliance with safety and quality standards. This establishes uniform inspection procedures, documentary requirements, and evaluation criteria for manufacturers, traders, distributors, and retailers of medical devices,
Philippines: Guidelines on the Inspection of Medical Device Establishments Read More »
The Medical Device Authority (MDA) of Malaysia has officially gazetted the Medical Device (Amendment) Regulations 2025 [P.U. (A) 330] on September 11, 2025. This amendment revises the fee structure under the Fifth Schedule of the Medical Device Regulations 2012 [P.U. (A) 500/2012] for the registration of Class A medical devices, effective January 1, 2026. To
Malaysia: Update on Fees for Class A Medical Devices Read More »
The Medical Device Authority (MDA) of Malaysia announced that Malaysia has been officially recognized as an Affiliate Member of the Medical Device Single Audit Program (MDSAP) by the MDSAP Regulatory Authority Council (RAC), effective September 16, 2025. This milestone aligns Malaysia with other participating regulatory authorities and strengthens its position in the global medical device
On September 30, 2025, the Secretariat General of the Ministry of Health of Indonesia issued a new Notification Letter titled “Deactivation of Electronic Catalogue Version 5”. This update follows the Letter from the Director of Digital Market Procurement LKPP and the Circular Letter from the Head of LKPP Number 2 of 2025 concerning the Deactivation
Indonesia: Deactivation of Electronic Catalogue Version 5 Read More »
On September 19, 2025, the Department of Health (DOH) issued Administrative Order No. 2025-0020, “Rescission of Administrative Order No. 2021-0038 dated June 11, 2021, titled ‘Framework for the Philippine Essential Medical Devices List and Price Reference Index.’” The DOH rescinded the 2021 framework to adopt a more dynamic approach in ensuring the availability of quality
Philippines: Rescission of Administrative Order on Essential Medical Devices Framework Read More »
The Thai FDA has published an infographic and FAQs detailing the renewal process for five types of medical device licenses. The guidance provides step-by-step procedures, timelines, fees, and frequently asked questions to support registrants in maintaining compliance. To view the official announcement: Infographic- กองควบคุมเครื่องมือแพทย์ (Thai FDA Official Website in Thai). FAQs: กองควบคุมเครื่องมือแพทย์ (Thai FDA Official
Thailand: FDA Infographic on Renewal Process and FAQs for Medical Device Licenses Read More »
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