Registration Overview
Overview of medical device registration requirements in Malaysia, including who must register, exemptions, and the registration cycle under Act 737.
Class A — Notification / Listing
Streamlined notification and self-declaration pathway for Class A medical devices under Malaysia's Medical Device Act 2012.
Class B — Full Registration
Full registration dossier requirements for Class B medical devices under Malaysia's Medical Device Act 2012 and Medical Device Regulations 2012.
Class C — Full Registration
Enhanced registration dossier and clinical evidence requirements for Class C medical devices under Malaysia's Medical Device Act 2012.
Class D — Full Registration
Maximum-depth design dossier and clinical requirements for Class D (highest risk) medical devices under Malaysia's Medical Device Act 2012.
IVD Registration
Registration dossier requirements specific to in vitro diagnostic medical devices (IVDs) under Malaysia's Medical Device Act 2012.
Registration Renewal
Device registration renewal process in Malaysia, including timelines, triggers, grace period, and change management during renewal under Act 737.
MyMDA Portal — Device Registration
Practical walkthrough of the MyMDA device registration submission workflow, common issues, and document upload best practices.