SaMD & Digital Health
MDA's regulatory approach to Software as a Medical Device (SaMD), AI/ML-driven software, mobile medical apps, and cybersecurity expectations in Malaysia.
In Vitro Diagnostics (IVD)
IVD-specific regulatory obligations in Malaysia beyond classification, including performance evaluation, reference materials, kit components, and post-market requirements.
Custom-Made Devices
Definition, exemption scope, and obligations for custom-made medical devices under Malaysia's Medical Device Act 2012 (Act 737).
Special Access Route (Exemptions)
Malaysia's Special Access Route for unregistered medical devices, including eligibility criteria, application process, and obligations under Act 737.
ASEAN Harmonisation & AMDD
Malaysia's participation in the ASEAN Medical Device Directive (AMDD), ASEAN Common Submission Dossier Template (CSDT), AHWP alignment, and IMDRF membership.
Labelling Requirements
Mandatory label elements for medical devices in Malaysia under Act 737, including Bahasa Malaysia requirements, IFU obligations, and language rules.
Device Grouping & Variants
MDA rules on grouping devices under a single registration, managing product variants, and size and configuration families in Malaysia.