Malaysia Issues New Rules For Medical Device Classification

On April 1, Malaysia’s Medical Device Authorities (MDA) issued a guidance document further classifying devices into 3 categories – 1. Non-invasive medical devices, 2. Invasive medical devices, and 3. Active medical devices. In addition to these categories, a number of new rules have also been outlined. For example, devices that include a medicinal product and devices manufactured with cells or human/animal tissues are Class D products. Devices used for contraception or the prevention of sexually transmitted diseases are Class C, but if such products are implantable or used on a long-term basis, they are considered Class D. If a device follows 2 or more rules, the device is determined by the highest Class. In the past, medical devices in Malaysia were only classified as Class A, B, C, and D depending on the risk of the device.