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Topic:MDA
All articles tagged “MDA”, aggregated across product categories, compiled from official sources.
Are Massage Devices Medical Devices in Malaysia? Using "Claims" to Judge the MDA Boundary
Whether massage chairs, massage guns and TENS/EMS electrotherapy devices need MDA registration depends on the "intended purpose" claimed by the manufacturer. This article explains the medical vs non-medical test, the separate line of electrical safety, and e-commerce listing compliance.
Malaysia Medical Device Labelling Rules: MDA/GD/0026 Mandatory Items, Language and Home-Use Requirements
Medical device labelling is governed by the Medical Device Act 2012 (Act 737) and guidance MDA/GD/0026. Labels must be legible, permanent and prominent, showing the device name, manufacturer and authorised representative, batch number, intended use and instructions; home-use devices must also be labelled in Malay with a paper instruction sheet.
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.
Malaysia Contact Lens Compliance: Corrective and Coloured Cosmetic Lenses Are Both Medical Devices — A Full MDA Registration Guide
In Malaysia, corrective contact lenses and non-corrective coloured cosmetic lenses are all medical devices under the Medical Device Act 2012 (Act 737), and must be registered with the MDA before going to market. This article covers classification, registration, labelling and import-channel compliance essentials.