Dec 7, 2018
EMERGO BY UL SUMMARY OF KEY POINTS:
Health Canada has issued a final email reminder to medical device companies regarding the regulator’s December 31, 2018 deadline for transitioning to the Medical Device Single Audit Program (MDSAP) for quality management system compliance.
According to the Health Canada notice, all Medical Device License (MDL) holders of Class II, III and IV devices must provide evidence of MDSAP transition to the agency before December 31. Companies that fail to do so may face suspension of their MDLs. The regulator has published a MDSAP Frequently Asked Questions (FAQ) web page explaining documentation submission requirements.
MDSAP certification will replace the Canadian Medical Device Conformity Assessment System (CMDCAS) for quality management compliance starting in January 2019.
EMERGO SUMMARY OF KEY POINTS:
EMERGO SUMMARY OF KEY POINTS:
EMERGO SUMMARY OF KEY POINTS: