Quick Answer IVD (in vitro diagnostic) medical devices are regulated by the MDA under the Medical Device Act 2012 (Act 737) and must be registered before they can be imported or sold in Malaysia. IVDs use their own 4-class risk classification system based on two axes: individual risk and public health risk. Class A IVDs …
IVD Registration in Malaysia: Requirements, Classification & How to Register Read More »
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 on 26 August 2026. The technical specifications, device list and timing details have not yet been published by the MDA. This guide captures information that is confirmed as of October …
Hologram Security Labels for Registered Medical Devices in Malaysia Read More »
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, submission systems (QUEST3+), and product category requirements updated as of September 2026. Quick Answer The NPRA (National Pharmaceutical Regulatory Agency) is Malaysia’s regulator for pharmaceutical products, health supplements, traditional medicines …
Malaysia NPRA Product Registration: What Does the Process Look Like? Read More »
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 government fees shown are current as of September 2026. CAB and LAR/consultant fees are market ranges and vary by provider. Quick Answer The total cost of registering a medical device …
Cost of Registering a Medical Device in Malaysia 2026 Read More »
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 renew. This guide reflects the new automated route, updated fees under the Medical Device (Amendment) Regulations 2025, and the MDA’s confirmed guidance that re-registration applications should be submitted one year …
How to Renew Medical Device Registration in Malaysia 2026 Read More »
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 medical devices. It is governed by Section 40 of the Medical Device Act 2012 (Act 737), Regulation 5 of the Medical Device (Duties and Obligations of Establishments) Regulations 2019, and …
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 effective 1 June 2026 expanding the device scope, the Medical Device (Duties and Obligations of Establishments) Regulations 2019, and updated MDA guidance as of August 2026. Quick Answer Post-Market Surveillance …
Post-Market Surveillance (PMS) for Medical Devices in Malaysia 2026 Read More »
Quick Answer Yes — you can change your Local Authorised Representative in Malaysia. Device registrations can be transferred from one LAR to another via a formal process with the Medical Device Authority (MDA). The critical variable is the cooperation of your outgoing LAR — because device registrations are held under the LAR’s Establishment Licence, the …
Can You Change Your LAR in Malaysia? The Full Transfer Guide Read More »
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 LAR is the legally responsible entity for post-market surveillance, mandatory problem reporting (adverse event reporting), field safety corrective actions, distribution records management, change notifications, and registration renewal. All of these …
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 a current GDPMD certificate; conduct due diligence on their regulatory expertise and track record; negotiate and sign a LAR agreement covering scope, responsibilities, and termination; issue a Letter of Authorization …
