Topic:口罩

Malaysia Mask / Glove / PPE Compliance: When It Counts as a Medical Device, MDA Registration and Test Standards

Masks, gloves and protective equipment are Act 737 medical devices "when used for a medical purpose", governed by the MDA under MDA/GD/0033 (masks and respirators) and MDA/GD/0058 (PPE); most are Class A, requiring registration with full test reports; purely industrial/general-purpose items are not medical devices.