Malaysia Offers Expedited Reviews for Devices Approved Elsewhere

Malaysia’s Medical Device Authority (MDA) has established an expedited review process for medical devices already approved in other jurisdictions including the U.S., Canada, Australia, the EU, and Japan.

In a new circular, the authority sets out criteria for quality management systems, post-market surveillance, and technical documentation for various classes of medical devices. The process for approving devices that are already sold in other countries is simpler and less costly than the standard medical device registration process, the circular says.

For example, for Class A (low-risk) devices, regulators will look at the device’s intended use and classification, the scope of the manufacturer’s quality management system, labeling, and certain aspects of the manufacturing process, the authority said.

Read the circular here: www.fdanews.com/01-23-17-recognizeddevices.pdf.