Malaysia medical device QA/RA blog

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Malaysian Regulators Issue Updated Conformity Assessment Guidance

The Malaysian Medical Device Authority (MDA) has published new guidance on its conformity assessment process in order to provide more information to authorized representatives, manufacturers and conformity assessment bodies, or CABs.

Malaysia Medical Device Authority (MDA) guidance on conformity assessmentsOne interesting item in the new guidance pertains to estimated timeframes for CAB reviews of medical devices, which the MDA states is two hours. (Longer CAB timeframe estimates had been stated in previous guidance documents.)

In addition, the MDA has included templates for conformity assessment reports (Annex A) and certificates of conformity (Annex B) in the guidance. Otherwise, no other significant changes to the Malaysian CAB assessment process have been included in the latest document.

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