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.

Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.

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