| OTech can assist in generating the required documentation which is required to sell a medical device in Canada. Note that the regulation has recently changed with regard to the different classifications, and that PACS systems now also require this registration.
In order for a device manufacturer to obtain a Canadian regulatory clearance to market their product, we will:
- Verify the Canadian medical device classification for the particular device (note that the Canadian classification is similar, but different from the US classification.)
- Depending on the classification, the manufacturer needs to obtain ISO 13488 or an ISO 13485 quality system certification from a Health Canada certified registrar. OTech can assist in generating the required documentation in the specified format.
- The vendor will than apply for a Canadian Medical Device Licence for Class II, III, or IV devices. For Class I devices a licence is not required but the manufacturer must obtain an Establishment Licence.
 |