Regulatory Affairs and Quality Assurance Consulting Services

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THE CHALLENGE

A US medical device held at Canadian Customs upon import

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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.

The Process

Medical Device Import Into Canada Initially Denied Entry

The Challenge

The Outcome

Need help to unblock regulatory hurdles in order to get products approved for sale in the Canadian market? Read how we've assisted companies faced with regulatory challenges.

The device was released by customs and has been available within the Canadian market without issue ever since.

Client said: "It is comforting to delegate to someone capable and knowledgeable and not have to worry. RAQA was a lifesaver for us from the start and we wholeheartedly recommend them."