Topic:IVD

Malaysia IVD In-Vitro Diagnostic Compliance: Classification and Registration for Rapid Tests, Pregnancy Tests and Glucose Meters

Pregnancy test kits, glucose meters, rapid test reagents and HIV tests are all in-vitro diagnostic medical devices (IVDs), governed under Act 737 and regulated by the MDA under a dedicated A–D risk classification. This article explains classification, the upgrade for self-testing, the registration process and common mistakes.