Dec 7, 2018

EMERGO BY UL SUMMARY OF KEY POINTS:

  • Health Canada’s December 31, 2018 deadline for MDSAP transition imminent.
  • Medical Device License (MDL) holders for Class II, III and IV devices must submit evidence of transition from CMDCAS to MDSAP by the December 31st deadline.

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.

Related Health Canada and MDSAP regulatory resources from Emergo by UL:

  • CMDCAS, MDSAP and Health Canada ISO 13485 quality management system consulting
  • On-site MDSAP training for medical device manufacturers
  • Health Canada Medical Device License (MDL) registration consulting
  • Webinar: MDSAP certification overview
  • Whitepaper: Transitioning to MSDAP compliance