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Canada - Medical Device Registration
We can assist you and your product to achieve Medical Device Registration in Canada
Medical device in Canada are regulated by the Medical Devices Regulations, which set out a system for classifying medical devices into one of four classes with Class I representing the lowest risk and Class IV representing the highest risk. Devices imported or sold in Canada must meet fundamental safety and effectiveness requirements and labelled in accordance with specified labelling requirements. All manufacturers wishing to import or sell Class II, III, or IV medical devices for use in Canada are required to obtain a Medical Device Licence. The medical device licensing process involves submission of a Medical Device Licence application, provide necessary documents including a valid Canadian Medical Devices Conformity Assessment System (CMDCAS) certificate. TUV Rheinland can help you access Canadian market for your medical device. Contact our Experts now for more details!
| Technical aspects | Safety |
| Market surveillance | Yes |
| Obligation | Mandatory |
| Factory inspection | No |
| Sample testing | No |
| Validity |
Registration licenses shall be renewed on a yearly basis. |
Product Scope
Medical devices (Class I to Class IV)
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