Topic:分級

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.