Can You Change Your LAR in Malaysia? The Full Transfer Guide
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 […]
LAR Post-Approval Responsibilities in Malaysia
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 […]
How to Appoint a LAR in Malaysia?
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 […]
What Is a Local Authorised Representative (LAR) in Malaysia?
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 in-country representative for a foreign medical device manufacturer. Under the Medical Device Act 2012 (Act 737), foreign manufacturers cannot register medical devices in Malaysia directly — they must appoint an […]
How Long Does Conformity Assessment Take in Malaysia? 2026 Guide
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 confirmed Malaysia–Singapore HSA reliance arrangement (1 March 2026), removal of the 1-year marketing duration requirement for the verification route, MDSAP QMS recognition, Thai FDA as a new reference authority, and […]
CAB vs MDA: Understanding Their Roles in Malaysia Medical Device Registration
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 classification system from 1 May 2025, and updated MDA guidance last revised 22 May 2026. Quick Answer The CAB (Conformity Assessment Body) and MDA (Medical Device Authority) play separate but […]
Do All Medical Devices Need CAB Assessment in Malaysia?
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 arrangement effective 1 March 2026, Class A fee changes effective 1 January 2026, and the withdrawal of MDA/GD/0066 on 16 February 2026. Quick Answer No — not all medical devices […]
What Is a Conformity Assessment Body (CAB)?
Quick Answer A Conformity Assessment Body (CAB) is an independent organisation registered by Malaysia’s Medical Device Authority (MDA) under the Medical Device Act 2012 (Act 737) to evaluate medical devices and quality management systems for regulatory compliance. For Class B, C, and D devices, a CAB must assess your technical documentation and issue a certificate […]
How to Prepare Technical Documentation (CSDT) for MDA Registration
Quick Answer Technical documentation for MDA registration in Malaysia is prepared in the Common Submission Dossier Template (CSDT) format, governed by MDA guidance document MDA/GD/0008. It must cover seven core elements: an executive summary, the Essential Principles conformity checklist, device description, design verification and validation summary, clinical evidence summary, labelling, and manufacturer information. Every section […]
