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.

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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