The Halal Product Assurance Organizing Agency (BPJPH) of the Republic of Indonesia has issued Regulation No. 3 of 2026 on the Form and Procedure for Displaying Non-Halal Information. This regulation provides guidance, legal provisions, and legal certainty regarding the required forms and procedures for displaying Non-Halal Information on products entering,
The Medical Device Authority (MDA), Malaysia has issued an Interim Directive on Implantable Device Traceability concerning the traceability requirements for implantable medical devices under Subregulation 3(2) of the Medical Device Regulations 2019. While the legal obligation for establishments to maintain traceability records down to the patient level remains in force,
The Medical Device Authority (MDA) has announced a revision to the requirements for foreign manufacturer contact details under the Guidance Document MDA/GD/0026: Requirements for Labelling of Medical Devices. The update forms part of the latest revision to Malaysia’s medical device labelling guidance and applies to both general medical devices and
The Medical Device Authority (MDA) announced the commencement of the Malaysia–China Joint Evaluation Pilot Programme, Pilot Phase 2, from 1 July to 30 September 2026 under the Global Harmonization Working Party (GHWP) Common Evaluation Reliance Practice (CERP) framework. The pilot introduces a Joint Evaluation approach between MDA Malaysia and NMDA
The Medical Device Authority (MDA) wishes to inform all stakeholders that the exemption from the Conformity Assessment Process by a Conformity Assessment Body (CAB) for the registration of COVID-19 Test Kits is no longer applicable following the withdrawal of the relevant circular letter on 23 February 2024. All subsequent registration
The Medical Device Authority (MDA) of Malaysia and the Ministry of Health, Labour and Welfare (MHLW) of Japan signed a Memorandum of Cooperation (MoC) on 10 June 2026 in Tokyo to strengthen regulatory cooperation in the medical device sector. Executed during the official visit of the Prime Minister of Malaysia
Subscribe to our Newsletter
Be the first to know about critical medical device regulation changes, market entry requirements, and industry shifts.
