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The Medical Device Authority (MDA) has published the draft for comments of the First Edition Guidance Document titled “CHANGE MANAGEMENT FOR REGISTERED MEDICAL DEVICES”. This document outlines general principles, categorization, reporting, and alternative pathways for managing changes. It employs a risk-based approach with illustrative examples. Read the full announcement to learn more: https://portal.mda.gov.my/index.php/announcement/1729-announcement-public-comment-first-edition-guidance-document-change-management-for-registered-medical-devices Purpose of […]

The Medical Device Authority (MDA) has published a draft of the Second Edition Guidance Document titled “Definitions of Medical Devices” for public comment. This guidance document defines accessories, components, and spare parts of medical devices, and provides examples to enhance clarity. Read the full announcement to learn more: https://portal.mda.gov.my/index.php/announcement/1730-announcement-public-comment-first-edition-guidance-document-definitions-of-medical-devices Purpose of the Guidance Document To

On 1 December 2025, the Medical Device Authority (MDA) issued an important update regarding the enforcement timeline for the Medical Device Import Permit (IP) requirement under the Customs (Prohibition of Import) Order 2023. The update provides: A revised enforcement date for the mandatory Import Permit requirement Continued application of existing import procedures during the transition

The Medical Device Authority (MDA) of Malaysia has issued an announcement regarding the implementation of a validity period for the Product Classification Letter, effectively revoking the previous announcement dated 1 April 2025. To read the full announcement: Implementation of Validity Period for Product Classification Letter [link] Key Updates 1. Introduction of Validity Period As stated

The Medical Device Authority (MDA) of Malaysia has announced the successful conclusion of the Malaysia–United States Agreement on Reciprocal Trade, marking a landmark achievement for the nation’s medical device industry. The announcement coincides with the ASEAN Summit 2025, underscoring Malaysia’s commitment to advancing international trade and regulatory cooperation in the healthcare sector. Scope Summary of

The Medical Device Authority (MDA), in collaboration with the Universiti Malaya (UM) research team, is conducting a study titled “Barriers, Risks, and Regulations in Malaysia’s Medical Device Industry”. Scope Summary of the online survey conducted jointly by the Medical Device Authority (MDA) and Universiti Malaya (UM) to identify barriers, risks, and opportunities within Malaysia’s medical

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.

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 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

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