BLOGS

Quick Answer Hong Kong uses a voluntary listing system (MDACS) with Class I–IV for general devices and Class A–D for IVDs, overseen by the Medical

Quick Answer MDA registration requires administrative documents (establishment licence, AR declaration, GMDN code), a completed CSDT, ERSP checklist, risk management file, clinical evidence, labelling and

Quick Answer The most common medical device classification mistakes in Malaysia include misclassifying based on product appearance rather than intended use, applying general device rules

If you’re bringing a diagnostic test, laboratory reagent, or testing kit into Malaysia, you’re dealing with a specific regulatory category that many manufacturers underestimate: In

Medical device manufacturers looking to enter the Malaysian market must comply with regulatory requirements set by the Medical Device Authority (MDA). Understanding how to register

If you’re planning to register a medical device in Malaysia, one of the first things you’ll need to figure out is your device classification. It

If you’re planning to bring a healthcare product into Malaysia, chances are you’ve asked this at some point: Do I go through MDA or NPRA?

Expanding into Southeast Asia sounds like the natural next step for many medical device companies. The demand is growing, the market is attractive, and opportunities

Entering the Malaysian healthcare market can be a complex process for foreign medical device manufacturers. Selling medical devices in Malaysia is strictly regulated by the

Manufacturers planning to enter the Malaysian healthcare market must understand the Medical Device Act Malaysia — the primary law governing the safety, registration, and distribution