Guide

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 …

What Is a Local Authorised Representative (LAR) in Malaysia? Read More »

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 …

How Long Does Conformity Assessment Take in Malaysia? 2026 Guide Read More »

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 …

CAB vs MDA: Understanding Their Roles in Malaysia Medical Device Registration Read More »

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 …

Do All Medical Devices Need CAB Assessment in Malaysia? Read More »

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 …

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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 …

How to Prepare Technical Documentation (CSDT) for MDA Registration Read More »

Quick Answer ISO 13485 is the international quality management system (QMS) standard specific to medical device manufacturers. While not strictly mandated by name under Malaysia’s Medical Device Act 2012, the Medical Device Authority (MDA) recognises it as the primary evidence of an acceptable QMS — and in practice, manufacturers must hold a certified QMS to …

ISO 13485 Why It Matters for Medical Device Registration in Malaysia Read More »

Quick Answer A Declaration of Conformity (DoC) is a mandatory document in which the manufacturer formally declares that their medical device complies with all applicable Essential Principles of Safety and Performance (EPSP) under Malaysia’s Medical Device Act 2012 (Act 737) and the Medical Device Regulations 2012. It must be prepared on the manufacturer’s letterhead, signed …

Declaration of Conformity (DoC) for Medical Device Registration in Malaysia Read More »

Quick Answer Hong Kong uses a voluntary listing system (MDACS) with Class I–IV for general devices and Class A–D for IVDs, overseen by the Medical Device Division (MDD). Malaysia uses a mandatory registration system under the MDA and Act 737, with Class A–D classification for all devices. Both require a local representative — Hong Kong …

Hong Kong vs Malaysia Medical Device Registration: Complete Comparison (2026) Read More »

Quick Answer MDA registration requires administrative documents (establishment licence, AR declaration, GMDN code), a completed CSDT, ERSP checklist, risk management file, clinical evidence, labelling and IFU, and ISO 13485 certification. Requirements scale by class — Class A submits directly to MDA; Class B, C, and D require a full CSDT and CAB conformity assessment first. …

Full Checklist of Documents for MDA Medical Device Registration Malaysia (2026) Read More »