Updated for 2026: The MDA launched an Automated Re-Registration Route within MeDC@St 2.0+ on 13 July 2026, giving eligible registration holders a faster pathway to
Quick Answer Vigilance reporting in Malaysia is the formal process by which manufacturers and their Local Authorised Representatives notify the MDA of incidents involving registered
Updated for 2026: Reflects MDA/GD/0070 Second Edition (September 2025) standardising PMS data to the past 3 years, the Medical Device (Designated Medical Device) Order 2026
Quick Answer Yes — you can change your Local Authorised Representative in Malaysia. Device registrations can be transferred from one LAR to another via a
Quick Answer After a medical device is registered in Malaysia, the LAR’s responsibilities do not end — they shift from registration to ongoing compliance. The
Quick Answer To appoint a LAR in Malaysia, you must: identify a company that holds a valid MDA Establishment Licence for the LAR role and
Quick Answer A Local Authorised Representative (LAR) is a Malaysia-based company or individual licensed by the Medical Device Authority (MDA) to act as the official
Updated for 2026: Reflects revised MDA timeline guidance (CAB ~1.5 months; MDA 14–20 days for Class A; ~30 working days for Class B–D), the permanently
Updated for 2026: Reflects the permanently confirmed Malaysia–Singapore HSA reliance arrangement (1 March 2026), import permit requirements via ePermit effective 2 January 2026, mandatory online
Updated for 2026: This guide reflects the Medical Device (Exemption) Order 2024, MDA Circular Letter No. 1 Year 2025, the permanent Malaysia–Singapore HSA regulatory reliance
