It's been one full month since the Medical Device Single Audit Program officially replaced the traditional Canadian Medical Devices Conformity Assessment System (CMDCAS) audits, and Health Canada is claiming success. Although 403 device-makers withdrew from the Canadian market because of the switch to MDSAP, it's nothing to be concerned about, a Health Canada spokesperson says.
It's been one full month since Health Canada's deadline for manufacturers to be certified to the Medical Device Single Audit Program came and went, and the message from that regulator is clear: All systems normal.
MDSAP – which allows firms to undergo one audit by an accredited third party to satisfy quality regulations for Canada,...