Health Canada Throws MDSAP Lifeline To Small Device-Makers

Device manufacturers with fewer than 45 employees will see a 10% reduction in audit time as they scramble to meet the agency's Medical Device Single Audit Program deadline to sell product in the country.

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• Source: Augusto Cabral/Shutterstock

Small medical device manufacturers worried about meeting Health Canada's upcoming deadline to be audited to the Medical Device Single Audit Program have been thrown a lifeline by the agency, whose MDSAP Consortium has reduced the amount of time that auditors will spend at companies' facilities.

In an Oct. 31 notice, Health Canada said device-makers with 45 or fewer employees will see a 10%...

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