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Following the enactment of the One License Per Establishment Role Policy outlined in the “General Directive of the Minister of Health No. 1/2024, in accordance with the provisions of the Medical Device Authority Act 2012 [Act 738]: Implementation of the One License Per Establishment Role Policy,” the Medical Device Authority (MDA) of Malaysia has declared

On May 23, 2024, the Medical Device Authority (MDA) of Malaysia issued a draft guidance document for the fifth edition of Change Notification for Registered Medical Devices, designated as MDA/GD/0020. The main highlights from this draft guidance document are as follows:• Establishments are required to identify the appropriate application type, either Single Application or Multiple

On April 2nd, 2024, the Medical Device Authority (MDA) of Malaysia announced the cancellation of the Circular of the Authority for Medical Devices (PBPP) Number 1/2022: Exemption from the Compliance Assessment Process by the Compliance Assessment Body (CAB) for The Registration of Covid-19 Test Kits. This requirement applies to manufacturers who want to register their

The Medical Device Authority (MDA) has released the Guidance Document, MDA/GD/0005, Second Edition, entitled “General Medical Device – Grouping” to assist the industry and healthcare professionals in achieving compliance with the Medical Device Act (Act 737) and its associated regulations. The guidance document has been updated to offer direction on determining the appropriate grouping for

On March 7th, 2024, the Medical Device Authority (MDA) of Malaysia, issued Medical Device (Exemptions) Order 2024 where the Medical Device (Exemption) Order 2016 [P.U. (A) 103/2016] is revoked. The legislation covers the following: Exemption from Registration of Medical DevicesAny medical device is exempted from registration under section 5 of the Act by the Minister

On December 14th, 2023, the Medical Device Authority (MDA) of Malaysia issued a requirement for surveillance report on implantable medical devices on the homepage of Medcast 2.0+ system. This requirement applies to distributors in which as per clause 27.(1) until 27.(3) in GDPMD, establishments that distribute implantable medical devices shall submit a surveillance report to

On November 16, 2023, the Medical Device Authority of Malaysia (MDA) published an infographicrelated to the medical device registration for In-Vitro Diagnostic (IVD) Medical Devices, where theMDA illustrated the possible ways to register an IVD Analyzer.Based on the infographic, the approaches below can be applied to register an IVD Analyzer:1) IVD AnalyzerThis applies to instruments

On 8th November 2023, the Medical Device Authority of Malaysia (MDA) published an announcement related with medical device advertisement applications. Commencing December 1st, 2023, the medical device advertisement applications can only be submitted to the MDA via email at advertisement@mda.gov.my. Any hard copies applications will not be processed by MDA. Processing fees shall be paid

Based on the Decision from the Mesyuarat Jawatankuasa Teknikal Pendaftaran Umum 2023, the Medical Device Authority of Malaysia (MDA) has established a transition period for specific requirements until December 31, 2023. Starting January 1, 2024, only the recognized Quality Management System (QMS) standards outlined in Table 1 will be accepted for new and re-registration of