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Manufacturers’ Worries Grow Over Canada’s MDSAP Deadline

Executive Summary

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.

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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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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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A growing number of medtech manufacturers have expressed interest in the Medical Device Single Audit Program since MDSAP became fully operational in January. The program has also drawn interest from regulatory agencies beyond those from the five participating countries, and a policy is being framed to admit new members.

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