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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.




Seminars - Dubai
APR 8-9 PACS Standards
APR 10-11 DICOM Adv. & EHR

Seminars - Dallas, TX
APR 16-17 PARCA CPAS Cert.
APR 18-21 PACS Sys Admin
APR 23-25 Comp. DICOM
APR 26-27 Comp. HL7


CBT Courses
PACS Clinical
PACS IT Basics
Health Informatics

Training
OsiriX Workshop

Software
OT-Heartbeat
Enterprise Server-Test Version





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