• 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.

• 2024-06-19 06:31:24

Starting 13 May 2024, Hong Kong Medical Device Division has excluded non-clinical devices from Medical Device Administrative Control System’s scope. Custom-made medical devices have also been excluded from this scope since 2 April 2024, and marketing approvals from Health Sciences Authority - Singapore has been accepted to support listing applications.

• 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.

• 2024-04-03 09:34:09

The Medical Device Authority (MDA) published new Guidance Document, on “POST MARKET INFORMATION EXCHANGE FOR ASEAN MEMBER STATES”, on January, 2024. This document serves as guidance on exchange of post market information among AMS.
In order to maintain patient safety and public health, it is necessary that all medical devices that are placed in the market meet appropriate standards of safety, quality and performance, and that they are used safely.

• 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.

• 2023-10-20 06:51:30

The Medical Device Authority (MDA) announced on 19th September that any event involving registered medical devices that occurs outside of the country is not required to be reported to MDA if the incident has been notified to the regulatory agency in the country where the incident happened and corrective action or precautions have been taken by the manufacturer or establishment.

• 2023-09-27 06:54:16

The Medical Device Authority (MDA) released implementation requirements for QMS and traceability forms on August 4th. Starting January 1, 2024, only the recognized QMS standards will be accepted for new and re-registration of medical devices.