As of January 1, 2019, according to the Canadian classification system, Class II, III, and IV Medical Devices manufacturers who intend to market their products in Canada will have to adapt to the MDSAP program.
The MDSAP is a single audit program that allows entities recognized by the Auditing Organizations to conduct a single audit on medical device manufacturers, verifying their compliance with the Good Manufacturing Practice (GMP) requirements of all program countries Regulatory Authorities.
Besides Canada, the following countries participate in the program:
However, Canada is going to adopt the MDSAP program beforehand, so starting from January 1, 2019 it will no longer accept quality systems that are not suitable for the MDSAP.
Moreover, in view of this mandatory deadline, Health Canada has long been issuing CMDCAS certificates expiring on December 31, 2018, regardless of the release date, because all CMDCAS certificates will no longer be valid after such date.
And how should a manufacturer intending to start marketing a Class II, III or IV device in Canada act?
The quality system certificate is a prerequisite for submitting a Medical Device License (MDL) to Health Canada, so things change if the manufacturer already has a Canadian Medical Devices Conformity Assessment System (CMDCAS) or he is seeking certification.
Among already certified companies, those with a certificate expiring on 12/31/2018 have some time to adapt to the MDSAP; while for those with a certificate expiring up to 2017, it is necessary to consider that Health Canada recently announced it will no longer accept CMDCAS certificates as early as January 1, 2018.
It is therefore necessary for the latter to adapt to the MDSAP as soon as possible and to obtain a compliant system certificate. The same applies to those approaching the Canadian market for the first time and have not yet obtained a system certification for Canada.
So? Are you ready for the MDSAP? Don’t let yourself be caught unprepared!
Silvia Scarpellini
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