A U.S. device company looking to import into Canada was not aware their product was in fact classified as a medical device, therefore could not sell in Canada without a Medical Device Establishment Licence (MDEL). Upon import, the product was held in storage at Canadian customs until they could get the MDEL. The company was referred to RaQa Consulting by a trusted logistics company.
RAQA acted quickly to get the MDEL in place and ensured all other necessary documentation (SOP's, etc.) were filed.
The medical device company began its business relationship with RAQA in 2013, and since then, they have worked together to solve any issues that arise as we as necessary renewals and updates—on budget and within deadlines.
Medical Device Import Into Canada Initially Denied Entry