• 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 07:44:34

The Thai Food and Drug Administration (Thai FDA) and the Medical Device Authority (MDA) of Malaysia have initiated the Pilot Reliance Project, a joint effort to facilitate medical device registration by recognizing each othe's regulatory approvals. The pilot project is effective from February 2026 until 30 April 2026.

• 2025-10-27 03:24:28

The Malaysia Medical Device Authority (MDA) has published the latest Conformity Assessment Body (CAB) guide and establishment guide to medical device registration submission in MeDC@St for Conducting Assessment by Way of Verification process, which includes updates on additional recognized regulatory authorities and revised verification procedures to help establishments streamline registration and ensure regulatory compliance.

• 2025-07-10 10:02:10

The Malaysia Medical Device Authority (MDA) has published the latest edition of Harmonised Borderline Products in ASEAN which provides an updated classifications list for products that may fall under medical device regulations across ASEAN member states. This update helps establishments to determine their products classification (medical device or non-medical device).

• 2025-05-29 09:42:50

Malaysia Medical Device Authority (MDA) authority issues the new guidance documents of Importation of Medical Device for Re-export (IRE), MDA/GD/0069 in March 2025. This guidance document outlines the procedure for importing medical devices into Malaysia for re-export purposes. It is particularly beneficial for importers and manufacturers by providing clear regulatory steps, approval requirements, and compliance guidelines to facilitate smooth procedure.

• 2024-10-10 09:23:31

The Medical Device Authority (MDA) announced the outcomes and implementation plan for the MDA-CAB 2023 Workshop held on December 6–7, 2023, as well as the current MDA-CAB 2024 Workshop Series I scheduled for March 1, 2024.

• 2024-07-30 03:35:49

The Medical Device Authority (MDA) announced the applications for medical device re-registration must be submitted online using MeDC@St 2.0+, in accordance with the Guidelines for Re-Registration of Registered Medical Devices (MD/GL/08). One year prior to the certificate expiration date, the system will display a re-registration option enabling the establishments to submit their applications.

• 2024-07-30 03:14:40

The Medical Device Authority (MDA) enforced the policy of medical devices imported from or exported to countries without diplomatic relations with Malaysia that are subject to trade restrictions. This policy was approved during the MDA Member Meeting No. 1/2024 and has been effective since April 26, 2024, under Circular Letter No. 1/2024.

• 2024-05-07 09:28:59

The Medical Device Authority (MDA) announced the cancellation of the Circular exempting the registration of Covid-19 Test Kits from the Compliance Assessment Process by the Compliance Assessment Body (CAB). The MDA Circular No. 1/2022 states the exemption of the compliance assessment process by the Compliance Assessment Body (CAB) under Section 7 of the Medical Devices Act 2012 (Act 737) for the registration of COVID-19 test kits under Section 5 of Act 737 either for self-use or for professional use.

• 2024-04-03 09:46:01

The Medical Device Authority (MDA) published new Guidance Document, on "MEDICAL DEVICE FOR PERSONAL USE", on January 30, 2024. This document serves as guidance for individuals who intend to bring any medical devices into Malaysia (referred as "import") for the purpose of personal use.
This guidance document specifies the requirements for the importation of personal use medical devices. This document applies to all home use medical devices that fall within the definition of a medical device, as defined in MDA/GD/0006: Definition of Medical Device, including in vitro diagnostic (IVD) medical devices. Not all medical device can fall under the category of personal use medical device.