• 2026-07-27 03:35:56

The Medical Device Authority (MDA) of Malaysia has published a revised guidance document, MDA/GD/0026: Requirements for Labelling of Medical Devices. This revision updates the requirements for inclusion of foreign manufacturer contact details on medical device labels. The revised requirements took effect on 22 May 2026.

• 2026-07-27 03:03:43

The Medical Device Authority (MDA) of Malaysia has announced a commencement of the second phase of The Malaysia–China Joint Evaluation Pilot Programme upon successfulness of Malaysia–China Medical Device Regulatory Reliance Programme (Pilot Phase I) in 2025. Pilot phase 2 will run from 1 July 2026 to 30 September. The programme enables the MDA and China's National Medical Products Administration (NMPA) to conduct a collaborative joint evaluation of eligible medical device registration applications under the GHWP Common Evaluation Reliance Practice (CERP).

• 2026-06-26 05:47:17

The Medical Device Authority (MDA) of Malaysia has published a new guidance document, Change Management for Registered Medical Devices (MDA/GD/0072). The guidance document will replace the current guidance document, Change Notification for Registered Medical Devices (MDA/GD/0020) and will be implemented following the official launch of MedCAST 3.0. Until such implementation takes effect, the current guidance document, MDA/GD/0020, shall remain applicable and in force.

• 2026-05-27 09:53:25

The Medical Device Authority (MDA) has published the latest edition of Import and/or Supply of Unregistered Medical Devices Under Special Access Exemption Application, MDA/GD/0043, which outlines the eligibility of personnel authorized to apply for the exemptions, specifies the procedures for notification, applicant responsibilities, and use of unregistered medical devices. The document is intended to facilitate timely access to medical devices for specific needs in healthcare settings.

• 2026-05-22 06:47:10

The Medical Device Authority (MDA) of Malaysia and the Thailand Food and Drug Administration (Thai FDA) have officially announced the successful completion of a three-month pilot phase, which took place from 1 February 2026 to 30 April 2026. Following this pilot phase, the full implementation of the MDA–Thai FDA Medical Device Regulatory Reliance Programme will now apply to the registration of Class B, Class C, and Class D medical devices.

• 2026-04-28 08:33:22

The Medical Device Authority (MDA) has published the latest edition of the guidance document Definition of Medical Device which provides additional clarification on the definition and regulatory interpretation of medical devices, including accessories, components, and spare parts. The document is intended to assist industry stakeholders in the proper identification of device classifications and ensuring compliance with the Medical Device Act 2012 (Act 737).

• 2026-04-28 08:14:56

The Medical Device Authority (MDA) has published the new guidance document, Application for Confirmation Status of Obsolete and Discontinued Medical Device (MDA/GD/0071). This publication was to assist establishments and healthcare professionals in understanding the applicable regulatory framework and in implementing appropriate control measures for obsolete and discontinued medical devices.

• 2026-04-01 08:37:41

The Malaysia Medical Device Authority (MDA) has implemented Circular Letter No. 1 Year 2026 that enforces a compulsory licensing for all medical device tenderers to possess a valid Establishment License. Compliance with Act 737 and related regulations is mandatory, with penalties for violations.

• 2026-04-01 07:01:44

The Medical Device Authority (MDA), Malaysia, announces two key updates for medical device registration. The latest labelling guidance introduces e-labelling requirements, while conformity assessments conducted by Singapore's Health Sciences Authority (HSA) are now recognized through a verification-based process. These updates aim to streamline registration and ensure compliance for medical devices in Malaysia.

• 2026-02-26 08:25:34

The Malaysia Medical Device Authority (MDA) has officially gazetted the Medical Device (Designated Medical Device) Order 2026, effective on 1 June 2026. The Order involved medical device primarily used in aesthetic, therapeutic, and clinical settings. To enhance safety and mitigate risks, designated medical devices shall comply with Malaysian regulatory requirement for entering the Malaysian market.