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Single Marketing Application Review For Multiple Jurisdictions On Horizon

 
• By Neena Brizmohun

Medical device makers could get their products to markets around the world faster if plans for a single premarket review program by international regulators go ahead.

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...

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