Challenges Prompt Canada To Adapt MDSAP Transition Plan
Health Canada is making it easier for device manufacturers to transition to the Medical Device Single Audit Program by the 2019 deadline.
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US FDA device center official William Maisel offered an update on the agency’s ongoing efforts at an industry conference last week, touting recent successes in Medical Device Single Audit Program (MDSAP) expansion and its Voluntary Medical Device Manufacturing and Product Quality Pilot Program.
As Health Canada presses on with adopting the Medical Device Single Audit Program, concern is growing that companies will struggle to get certified in time.
The European Medicines Agency has partnered with eight institutions having access to real-world healthcare data to enable its DARWIN EU project to deliver real-world evidence to the EU medicines regulatory network when needed.