CMDCAS (Canada)
For medical devices (active/non-active and IVDs) classified into Class II, III or IV under Canadian Medical Devices Regulations, you are required to obtain a device license for each product before you export it to the Canadian market in accordance with regulations (SOR/98-282). Medical device licenses are granted by Health Canada. In order to obtain a license, you must submit the ISO 13485 certification issued by a CMDCAS registrar based on the Canadian Medical Devices Conformity Assessment System (CMDCAS) Certificate to Health Canada, along with the supporting information to testify the safety and effectiveness of the device.
TÜV-SÜD America, a member of the TÜV-SÜD Group is accredited by Standards Council of Canada as a registrar. In Japan, the CMDCAS certification services are provided through MHS Department of TÜV-SÜD Japan.
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At TÜV-SÜD Japan we have Japanese auditors who are qualified to provide services related to Canadian Medical Devices Regulations for various medical devices and IVDs product ranges. Obtaining a CMDCAS certification can be achieved by conforming to the requirements unique to Canadian Medical Devices Regulations in addition to the requirements of the ISO 13485 Quality Management System. You can obtain other certifications of other standards or regulations at the same time you obtain CMDCAS certification.
When considering exporting medical devices or IVDs to the Canadian market, please contact TÜV-SÜD Japan.
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