Malaysia Concludes Classification Guidance Comment Period

Malaysia’s MDA regulatory body, founded a decade ago, has concluded the public comments period for parties interested in submitting feedback on its new medical device guidance, MDA/GD/0009.

Offering numerous examples, MDA/GD/0009 provides classifications of medical devices known as active, invasive and noninvasive, as well as standards for combination, disinfectant and contraceptive devices, and those with integrated human or animal tissue.

From class A (low risk), through low-moderate (class B), moderate-high (class C) to high risk (class D), Malaysia’s device classification approach is risk-based.