I've been reviewing the following Health Canada documents:
(1). Private Label Medical Devices Q&A
(2). Guidance Document - Private Label Medical Devices
My confusion is that (1) states:
"...the private label manufacturer does not have to submit ISO 13485/88 certification in order to apply for a private label device licence."
But (2) states:
"...private label manufacturers and the devices that they market must comply with the requirements of the Medical Devices Regulations."
So, by (2), private label manufactures would be subject to the Regulations (SOR-98-282):
"(f) a copy of the quality management system certificate certifying that the quality management system under which the device is manufactured satisfies National Standard of Canada CAN/CSA-ISO 13485:03"
Is this not a contradiction? Most guidance documents (as well as posts here at the Cove) seem to indicate that private label manufacturers do not necessarily have to have 13485 QMS in place.
However, if private label manufacturers are subject to the CMDRs then it seems a 13485 QMS is a requirement...
(1). Private Label Medical Devices Q&A
(2). Guidance Document - Private Label Medical Devices
My confusion is that (1) states:
"...the private label manufacturer does not have to submit ISO 13485/88 certification in order to apply for a private label device licence."
But (2) states:
"...private label manufacturers and the devices that they market must comply with the requirements of the Medical Devices Regulations."
So, by (2), private label manufactures would be subject to the Regulations (SOR-98-282):
"(f) a copy of the quality management system certificate certifying that the quality management system under which the device is manufactured satisfies National Standard of Canada CAN/CSA-ISO 13485:03"
Is this not a contradiction? Most guidance documents (as well as posts here at the Cove) seem to indicate that private label manufacturers do not necessarily have to have 13485 QMS in place.
However, if private label manufacturers are subject to the CMDRs then it seems a 13485 QMS is a requirement...