How to Register an IVD in Malaysia: A Step-by-Step Guide
Quick Answer To register an IVD in Malaysia, the manufacturer or their appointed Local Authorised Representative (LAR) must classify the device, prepare a technical dossier (CSDT), complete CAB conformity assessment if Class B, C or D, then submit the application through the MeDC@St portal. The MDA target review timeline is 180 days from application acceptance. …
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