April 2026

The Medical Device Authority (MDA) of Malaysia has published the First Edition of the Guidance Document on Application for Confirmation Status of Obsolete and Discontinued Medical Devices. This guidance provides clarity on the regulatory pathway for managing obsolete and discontinued medical devices in Malaysia, particularly in situations where such devices may no longer fully comply

The Medical Device Authority (MDA), Ministry of Health Malaysia, has officially joined the WHO Collaborative Registration Procedure (CRP) as a participating National Regulatory Authority (NRA) for WHO-prequalified in vitro diagnostic (IVD) products, effective 3 February 2026. This reliance-based mechanism allows MDA to leverage WHO prequalification assessments to accelerate the national registration process, reduce duplication of

The Medical Device Authority (MDA) of Malaysia has released the Third Edition Guidance on special access for unregistered medical devices. This update introduces a more structured and stricter process, replacing the previous notification-based system (including email submissions and Route A/B classification) with a single, mandatory online application via the MeDC@St system. Eligibility is now limited