Members of the International Medical Device Regulators Forum are taking the model for their single audit MDSAP initiative to the next level by exploring whether it can be used for a program that would let multiple jurisdictions rely on a single review of a marketing application.
The medical device single review program (MDSRP) is in the fledgling stage. The IMDRF discussed the initiative last month in the context of a new work item proposal (NWIP) to create new/updated guidance on the essential principles of safety and performance of devices
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