August 2026

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 policy is currently under […]

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 In-Vitro Diagnostic (IVD) medical devices.

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 / NMPA China, where both

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the Conformity Assessment Process by a Conformity Assessment Body (CAB) for the registration of COVID-19 Test Kits is no longer applicable following the withdrawal of the relevant circular letter on 23 February 2024.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 applications, including applicable re-registration applications