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Canada: Product Licensing
The legislation applied and the route to market approval in this country, is different from that in the EU and in the USA. Unlike the USA, the approach for device classification is similar to that in the EU, but the implications of the product class on documents required with the device licence application is different. BioTop Medical can assist you to determine the classification of the device, the selection of the applicable standards as well as with setting up the documents to be submitted to Health Canada.
An important aspect of the whole process is good communication. BioTop Medical has extensive experience in communication with all stakeholders in the development and production of medical devices, including the Health Canada reviewers. Clear, simple and precise wording is used to ensure that the necessary details are shared in a practical and appropriate fashion preventing unwanted delays on the critical path to market approval.