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Malaysian Low-Risk Devices Exempted From Conformity Assessment Process, But Registration Mandatory

This article was originally published in Clinica

Executive Summary

The Malaysian government exempted all types of Class A (lowest-risk) devices from conformity assessment requirements as of April 18 to make it easier for companies to bring such products to the market. These devices, however, will have to continue complying with other regulatory requirements such as labelling and post-marketing commitments.

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