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In line with the issuance of Circular Letter No. 1 Year 2023 entitled “Permission for Placement in the Market of Human Immunodeficiency Virus (HIV) Disease Self-Test Kits,” the Medical Device Authority (MDA) of Malaysia has taken a crucial step by releasing the Guidance Document MDA/GD/0065 entitled “Placement of HIV Self-Test (HIVST) Kit in Malaysia Market”. …

Malaysia: MDA Released Guidance Document MDA/GD/0065: Placement of HIV Self-Test (HIVST) Kit in the Malaysian Market Read More »

The Ministry of Health (MoH) of Malaysia has initiated various efforts to combat HIV/AIDS infection in the country ever since the first detected case in 1986. One of which is by introducing an HIV self-testing (HIVST) as a pivotal method for Test and Treat HIV/AIDS. This initiative aims to encourage a larger segment of key …

Malaysia: MDA released Circular Letter No. 1 Year 2023: Permission for HIV Self-Test Kits Placement in the Malaysian Market Read More »

The Medical Device Authority (MDA) of Malaysia has released a draft guidance document entitled ‘Importation of Medical Device for Re-Export’ for public review and feedback. The key takeaways of this draft guidance document are as follows: 1. Scope: Applies to all products that fall within the definition of medical device, as defined in MDA/GD/0001: Definition …

Malaysia: Draft Regulation for Public Comments: Importation of Medical Device for Re-Export Read More »

The Medical Device Authority (MDA) of Malaysia has released a draft guidance document entitled “Wearable Medical Device” for public review and feedback. The key takeaways of this draft guidance document are as follows: Scope: To determine the wearable products that fall within the definition of medical device as stipulated in Section 2 of Medical Device …

Malaysia: Draft Regulation on ‘Wearable Medical Device’ for Public Comments Read More »

Medical Device Authority (MDA) has released a draft guidance document titled ‘Importation of Medical Device for Personal Use’ for public review and feedback. The guidance document will be applicable 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 …

Malaysia: MDA Invites for Public Feedback on draft of First Edition Guidance Importation of Medical Device for Personal Use Read More »

The Medical Device Authority (MDA) released the Third Edition Guidance Document of Medical Face Mask and Respirator (MDA/GD/0033) on May 19, 2023. This guideline was intended to provide clarification on medical face masks and respirators regulated under the Section 2 of Medical Device Act (Act 737) and is applicable to establishments, healthcare facilities, and public …

Malaysia: MDA Released Third Edition Guidance Document on Medical Face Mask and Respirator (MDA/GD/0033) Read More »

Starting May 2, 2023, the Medical Device Authority of Malaysia (MDA) will implement the use of ‘Electronic Medical Device Registration Certificate’. This electronic medical device registration certificate can be downloaded from the MeDC@St2.0+ system once the application status is deemed as complete. A transition period up until December 31, 2023, is given to the establishment, …

Malaysia: MDA Announced Transition Period for the Implementation of Electronic Medical Device Registration Certificate Read More »

On March 23rd  2023, the MDA announced that they will withdraw the medical device registration (new and re-register) application and change notification application that has not been completed within 30 working days, starting from 1st April 2023. A transitional period will be given to the applicant until May 1st for the full implementation on withdrawal …

Malaysia: MDA Announced Withdrawal of Incomplete Medical Device Registration (New and Re-Register) and Change Notification Application Read More »

On February 2023, Malaysia’s Medical Device Authority (MDA) released a guidance document for the requirements of Product Classification. This guidance document is a revised version of MDA/GL/06 that was released in October 2021,that provides guidance, reference, and clarification on how to apply for Product Classification that are regulated under the Medical Device Act (Act 737). …

Malaysia: MDA Released Second Edition Guidance Documents for Product Classification Read More »

On March 9 2023, the MDA has announced the release of the Second Edition Guidance Document “Classification Of Rehabilitation, Physiotherapy and Speech Therapy Device” (MDA/GD/0061). This guidance document was prepared by the Medical Device Authority (MDA) to provide the classification of a list of products used for rehabilitation, physiotherapy, and speech therapy by determining whether …

Malaysia: MDA Issued Second Edition Guidance Document (MDA/GD/0061) Classification Of Rehabilitation, Physiotherapy and Speech Therapy Device Read More »

On March 1st 2023, the MDA released the First Edition Guideline Document “Notification of Custom-Made Medical Devices” (MDA/GD/0064). This guidance document is intended to provide guidance for the requirements of custom-made medical devices that are eligible to be exempted under Medical Order 2016.   It also specifies the specific requirements and notification process to obtain permission …

Malaysia: MDA Issued the First Edition Guidelines on “Notification of Custom-Made Medical Device” (MDA/GD/0064) Read More »