• 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.

• 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.

• 2024-07-30 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.

• 2024-04-03 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.

• 2024-03-01 07:14:04

The Medical Device Authority (MDA) published the Second edition Guidance Document, "Guidance on General Medical Device", on January 30, 2024. This guidance document provides aims to help determine the appropriate grouping for medical devices in the medical device registration application. This document applies to all products that fall within the definition of medical device that has been specified in the Guidance Document: Definition of Medical Device (MDA/GD/0006) excluding In-vitro Diagnostic Medical Device.

• 2023-11-20 01:38:47

The Medical Device Authority (MDA) announced on November 28th that the implementation of a fully electronic medical device registration certificate will start on November 1, 2023. MDA will only issue an electronic registration certificate for applications approved after November 1, 2023.