Medical device registration in Canada
Canada is one of the early implementers of medical device regulations back in 1975. Their regulations were strengthened further in 1998 with the implementation of Medical Device rules, SOR/98-282 in lines with International Medical Device Regulators Forum (IMDRF). With risk-based classification in implementation, decoding them becomes crucial for deciding on whether to apply for Establishment License and Regulatory approval. Canada also has other certification before approval. With stringent regulations for post-market surveillance and special regulations for implanted devices, procuring device market approval in the country may prove challenging.
How to register for your medical devicein Canada
Process flow
Titansmedical can help you with medical device or IVD registration, act as your Authorized representative and support you with distributor identification and importation.
