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Challenges Prompt Canada To Adapt MDSAP Transition Plan

 
• By Vibha Sharma

Health Canada is making it easier for device manufacturers to transition to the Medical Device Single Audit Program by the 2019 deadline.

Meeting
Manufacturers are facing challenges in scheduling MDSAP audits

Health Canada has clarified that it will not take enforcement action against device manufacturers who do not have a valid certificate under the Medical Device Single Audit Program (MDSAP) by the end of 2018, but are able to demonstrate that they underwent an MDSAP audit over the course of the year.

Device manufacturers were initially required to submit a valid MDSAP certificate (using form F202 for Submission of a New or Modified Quality Management System Certificate) to Health Canada's Medical Devices Bureau by Dec. 31, 2018. The new certificates were needed to demonstrate that manufacturers are complying with MDSAP requirements, which would fully replace the current Canadian Medical Devices Conformity Assessment System (CMDCAS) on Jan. 1, 2019

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