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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

On September 12, 2025, the Medical Device Authority (MDA) of Malaysia released the Second Edition of Guidance Document MDA/GD/0070. This updated guide provides establishments, manufacturers, and authorised representatives with revised instructions for medical device registration and abridged conformity assessment via the MeDC@St system. The revisions align with the Medical Device Act 2012 (Act 737), the

On September 12, 2025, the Medical Device Authority (MDA) of Malaysia released the Second Edition of Guidance Document MDA/GD/0068: Conformity Assessment Body (CAB) Guide for Conducting Conformity Assessment by Way of Verification. This update aims to improve consistency, transparency, and efficiency of conformity assessments under Malaysia’s medical device regulatory framework. Scope Guidance document detailing instructions

On 19 September 2025, the Medical Device Authority (MDA) of Malaysia announced that Malaysia has officially become an Affiliate Member of the Medical Device Single Audit Program (MDSAP). This significant milestone aligns Malaysia with other participating regulatory authorities and strengthens its position in the global medical device regulatory framework. Scope The announcement marks Malaysia’s formal

On 28 August 2025, Futurise Sdn Bhd, a wholly-owned subsidiary of Cyberview Sdn Bhd under the Ministry of Finance, in collaboration with the Medical Device Authority (MDA), hosted RegTalk 2025: AI Medical Devices in Malaysia – Balancing Innovation and Safety at the Siemens Healthineers Experience Center, Kuala Lumpur. The session brought together regulators, industry leaders,

On August 18, 2025, the Medical Device Authority of Malaysia (MDA) has updated the infographic (only editorial changes) related to REQUIREMENTS ON QUALITY MANAGEMENT SYSTEM (QMS) AND TRACEABILITY FORM applies to new medical device applications and re-registration medical device applications submitted from 1 January 2024. This infographic refers to the announcement on 4th August 2023