BLOGS

New 2026 initiative: The MDA has introduced the Hologram Security Label for registered medical devices on 5 August 2026, with the launch at IMDEC 2026

Updated for 2026: Reflects NPRA’s recognition procedure pilot launched May 2026 for FDA and EMA-approved drugs, targeting a 60-working-day review timeline. All NPRA registration pathways,

Updated for 2026: Fee tables reflect the Medical Device (Amendment) Regulations 2025 [P.U.(A) 330], gazetted 11 September 2025 and effective 1 January 2026. All MDA

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