BLOGS

Quick Answer A Conformity Assessment Body (CAB) is an independent organisation registered by Malaysia’s Medical Device Authority (MDA) under the Medical Device Act 2012 (Act

Quick Answer Technical documentation for MDA registration in Malaysia is prepared in the Common Submission Dossier Template (CSDT) format, governed by MDA guidance document MDA/GD/0008.

Quick Answer ISO 13485 is the international quality management system (QMS) standard specific to medical device manufacturers. While not strictly mandated by name under Malaysia’s

Quick Answer A Declaration of Conformity (DoC) is a mandatory document in which the manufacturer formally declares that their medical device complies with all applicable

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