Are you concerned about successfully transitioning your business into the Canadian marketplace? We often answer these kind of questions from our customers, and you can always contact us for more information.
Q. Will my company actually sell products in Canada?
A. Health Canada distinguishes between companies that sell medical devices and those that are, for example, contract manufacturers, sterilizers, design houses or services companies. Such companies only require a ISO 13485 certificate; CMDCAS certification is required only for medical device manufacturers that are selling products in Canada.
Q. Can I leave out Design Control if I only have Class II products?
A. Yes. However, BSI strongly advises that all companies who are design-responsible include Design Control in the scope of registration.
Q. Do my labels have to be in both French and English?
A. For most devices, only English is required as the main language on labels and instructions for use. Both languages are required for some devices, however, and companies should be able to demonstrate that they are capable of producing a label and the IFU in French.
Q. Does BSI submit my certificate to Health Canada?
A. No. Submitting the certificate is always the manufacturer’s responsibility, but BSI is very proactive on certificate change requests (which occur frequently with CMDCAS certificates).
Q. Will BSI send my report with all findings to Health Canada?
A. Yes. If Health Canada requests any company’s report, we are obligated to send this to them.