Topic:醫療器材

Medical Devices

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.

Medical Devices

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.

Medical Devices

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.

Medical Devices

Malaysia Home-Use Medical Devices (Blood Pressure / Glucose Meters): MDA Registration, Classification and Malay Labelling

Blood pressure monitors, glucose meters, thermometers and other home-use medical devices are Act 737 medical devices; commercial sale requires MDA registration, and glucose test strips are IVDs. Labels must be in Malay with a paper insert; personal-use imports are exempt under the Medical Device (Exemption) Order 2024.

Medical Devices

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.

Practical Guides

Introducing the MDA (Medical Device Authority): Who Regulates, What They Regulate, and How to Register

The MDA (Medical Device Authority) is a statutory body under Malaysia's Ministry of Health, established under Act 738 and enforcing the Medical Device Act (Act 737), responsible for device registration, establishment licensing and market surveillance. This article helps you understand its powers, the risk classification, and the MeDC@St registration path.

Medical Devices

Medical Device Risk Classification A / B / C / D (Malaysia)

Malaysian medical devices are classified from low to high risk into Class A, B, C, and D, determined by MDA under the ASEAN/GHTF rules. The class dictates whether you need a CAB conformity assessment, how much you pay in fees, and how long the process runs. This article explains the four-class definitions, the deciding factors, and common misconceptions.

Medical Devices

MDA Medical Device Registration Overview (Medical Device Act 2012 / Act 737)

Every medical device in Malaysia is regulated under the Medical Device Act 2012 (Act 737) and overseen by the Medical Device Authority (MDA). Before a device can be imported, sold, or placed on the market, it must first obtain an establishment licence and complete device registration. This article walks you through who must register, the four-step process, costs, and timelines.

Medical Devices

Authorised Representative (AR) for Medical Devices: a must for foreign manufacturers (Malaysia)

An overseas medical device manufacturer cannot register directly with MDA; it must first appoint a licensed Local Authorised Representative (AR) in Malaysia. The AR holds the device registration, liaises with MDA on the manufacturer's behalf, and takes on the post-market obligations. This article explains the AR's role, obligations, and key selection points.

Medical Devices

Do aesthetic / laser devices count as medical devices? (Malaysia)

Effective 1 June 2026, under the Medical Device (Designated Medical Device) Order 2026, Malaysia has designated a range of medical lasers, HIFU, and liposuction devices as medical devices requiring registration with MDA under Act 737. This article explains what is now regulated, the status of IPL/RF, and the compliance essentials.