The Medical Device Single Audit Program (MDSAP) Pilot will conclude December 31, 2016.
MDSAP will replace the current Canadian Medical Devices Conformity Assessment System (CMDCAS) program, even in situations when a manufacturer intends to sell only in Canada. MDSAP will be the sole mechanism for demonstrating compliance with the quality management system (QMS) requirements of the Medical Device Regulations.
The implementation of the MDSAP will begin on January 1, 2017 with a two year transition period:
- During the transition period, HC will accept certificates issued under both CMDCAS and MDSAP.
- As of January 1, 2019, only MDSAP certificates will be accepted.
All CMDCAS-recognized registrars have stated their intentions to apply to be authorized MDSAP AOs.