FDAnews Device Daily Bulletin

Malaysia Issues New Mandatory Device Reporting Requirements

June 22, 2017

Companies will need to report within 48 hours from discovery if a medical device sold in Malaysia presents a serious threat to the public health according to new requirements released by Malaysia’s Medical Device Authority.

The new reporting criteria were designed to better delineate the seriousness of problems associated with medical devices, and include different reporting requirements depending on circumstances. If a device leads to the death or serious deterioration in health to a patient, “or could do so were the incident to recur,” the adverse event must be reported within 10 days of discovery.

Finally, a failure of the device or “a deterioration in its effectiveness” or inadequacy in labeling must be reported within 30 days.

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