Classification Overview
Malaysia's four-tier risk-based medical device classification system (Class A–D) aligned with GHTF/IMDRF principles under the Medical Device Regulations 2012.
Class A — Low Risk
Classification criteria, regulatory obligations, and notification pathway for Class A (lowest risk) medical devices under Malaysia's Medical Device Act 2012.
Class B — Low-Medium Risk
Classification criteria and full registration requirements for Class B medical devices under Malaysia's Medical Device Act 2012.
Class C — Medium-High Risk
Classification criteria and enhanced registration requirements for Class C medical devices under Malaysia's Medical Device Act 2012.
Class D — Highest Risk
Classification criteria and full design dossier requirements for Class D (highest risk) medical devices under Malaysia's Medical Device Act 2012.
IVD Classification
In vitro diagnostic device classification under Malaysia's Medical Device Act 2012 and Medical Device Regulations 2012.
Classification Rules Reference
Summary of the medical device classification rules from the Medical Device Regulations 2012, with examples and guidance on applying them.