The Medical Device Authority (MDA) has announced a new enhanced process to facilitate the resolution of classification risk disputes between Establishments and Conformity Assessment Bodies (CABs). This initiative aligns with the Medical Device Act 2012 (Act 737) and aims to improve consistency and clarity in determining the appropriate classification for
The Medical Device Authority (MDA) has issued an updated regulatory approach regarding the use of expired EC Certificates for the new registration of medical devices in Malaysia. This revision is in response to ongoing challenges associated with the transition to the EU Medical Device Regulation (EU MDR) and In Vitro
The Medical Device Authority (MDA) reminds all licensed establishments of the official requirements for re-registering medical devices in Malaysia, in accordance with the latest Guidance Document MDA/GD/0070 titled “Guide for Medical Device Establishment Conformity Assessment by Way of Verification & Submission of Medical Device Registration in MeDC@St.” Under this guidance,
On 3 June 2025, the Medical Device Authority (MDA) issued a media statement highlighting its ongoing efforts to ensure that online advertisements of medical devices comply with regulatory requirements under the Medical Device Act 2012 (Act 737). The objective is to safeguard public health and safety by preventing the sale
The Department of Health (DOH) has issued Department Circular No. 2025-0240, temporarily suspending the implementation of Administrative Order (AO) No. 2024-0016 entitled “Implementing Guidelines on the New Schedule of Fees and Charges of the Food and Drug Administration,” in response to feedback and concerns raised by various sectors and stakeholders.
In support of digital health product innovation, the Health Sciences Authority (HSA), Singapore, collaborated with the Ministry of Food and Drug Safety (MFDS), Korea, to publish guiding principles for conducting clinical trials of machine learning-enabled medical devices (MLMD). This guideline version is effective from 11 December 2024. Core Guiding Principles
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