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On December 12th, 2023, the MDA issued 2 (two) guidance documents as follows: MDA/GD/0062 Harmonised Classification of Medical Devices in ASEAN, Second Edition. MDA/GD/0063 Harmonised Borderline Products in ASEAN, Second Edition. These are the highlights of each regulation: Harmonised Classification of Medical Devices in ASEAN 2nd Edition (MDA/GD/0062) Harmonised Borderline Products in ASEAN 2nd Edition

On 26th October 2023, the Medical Device Authority of Malaysia (MDA) published an announcement on the implementation of the use of electronic medical device registration certificate beginning November 1, 2023. With this move for applications approved after 1 November 2023, only electronic medical device registration certificates will be issued by MDA. Instead, the establishment can

On 23rd October 2023, the Medical Device Authority of Malaysia (MDA) published an announcement that the Certificate of Free Sale (CFS) will only be issued for registered medical devices, following the announcement made by the Chief Executive of MDA during MDA High Performance Project on 7th June 2023. With this move, MDA ceases the issuance

On July 14, 2023, the Medical Device Authority of Malaysia (MDA) announced a transition period of registration with exemption from compliance assessment process by the Compliance Assessment Body (CAB) for the registration of COVID-19 test kits based on Circular Letter Number 2/014. In accordance with Number Circular 2/2014, the evaluation of the COVID-19 test kit

The Medical Device Authority of Malaysia (MDA) announced the use of expired EC Certificates for new registration and re-registration of medical devices under certain conditions. This new approach was made due to unpredictable timeline and issues in relation to the transition to the EU MDR and to ensure a continuous supply of medical devices in

The Medical Device Authority of Malaysia (MDA) withdrawn the guidance document MDA/GD/0059 for COVID-19 RTK (SELF – TEST) – REQUIREMENTS from the MDA website on June 8, 2023. The guidance document was initially established and published with the intention to give specific requirements for conditional approval of Covid-19 RTK (self-test) to be placed in the

The Medical Device Authority of Malaysia (MDA) announced that enhancements have been made to the MeDC@St 2.0+. For notification module, an improved features have been added to the Clinical Research Use sub-module as follows: The online form has a new look and allows batch uploads on medical device listings. Print Application that allows printing of

Malaysia’s Medical Device Authority (MDA) released a guidance document for the requirements of MEDICAL GAS SYSTEM – REQUIREMENTS FOR REGISTRATION. This guidance document will serve as a revised version of MDA/GD/0057 that was released in June 2020, which provides information on the requirements for registration of medical gas system “placed in market” as defined in

On 11 January 2023, the Medical Device Authority (MDA) of Malaysia released the Fifth Edition Guideline Documents for Drug-Medical Device and Medical Device-Drug Combination Products. The revised guideline document covers the following matters : Revision on Changes/Variation to Particulars of a Registered Combination Product. Revision of Post-Marketing Activities: Management of Incident Involving Registered Combination Product

On January 11 2023, the MDA has announced the First Edition Guideline Document “How To Submit An Application For Registration Of A Refurbished Medical Device” (MDA/GL/10). This guidance document was prepared by the Medical Device Authority (MDA) to help the industry and healthcare professionals in their quest to comply with the Medical Device Act (Act

On 14 December 2022, the Medical Device Authority of Malaysia (MDA) has published an announcement on how to keep up with the MDA for their latest regulatory information and activities, which also known as Medical Device Authority-Regulatory Information Subscription (MDA-RIS). This program of e-mail notification subscription is an initiative by the MDA, to provide the

On 16 December 2022, the Medical Device Authority (MDA) of Malaysia has published an announcement to emphasize that all Conditional Approval and Special Access for COVID-19 test kits have been halted.  Any future placement of COVID-19 test kits on the Malaysian market shall be subjected to their registration under section 5 of the Medical Device