Topic:註冊

All articles tagged “註冊”, aggregated across product categories, compiled from official sources.

Designated Importer and Sole Agent: Who Holds Your Malaysian Product Registration?

Registration for most controlled products must be held by a local entity. Understand the difference between a designated importer, a sole agent and setting up your own subsidiary, plus the contractual risk of who owns the registration.

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.

Traditional Medicine

Classification and Registration of Topical Pain-Relief Liquids / Essential-Oil Balms (Malaysia)

Are medicated oils, rheumatism oils, and essential-oil balms cosmetics or traditional medicine in Malaysia? It comes down to therapeutic claims and active ingredients. This article clarifies the three classification boundaries, DRGD ingredient limits, and NPRA registration essentials.

Traditional Medicine

NPRA Registration for Medicated Plasters / Patches (Malaysia)

Pain-relief patches and medicated plasters are classified as traditional medicine in Malaysia and must be registered with NPRA to obtain a MAL(T) number and carry a Meditag security label. This article breaks down the classification boundaries, registration process, and import essentials.

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.