Comparative Study on Regulatory Requirements and Approval of Medical Devices in Australia & Canada

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Kartik M. Shah
Rushikesh V. Chavan
Amit P. Narang
Prathmesh S. Pawar
Girish A. Kashid
Gowtham Menon
Ravindra C. Sutar


Medical device is evolving market so it is needed to be regulated to maintain its Quality, Safety and efficacy. Therapeutic goods administration (TGA) regulates medical devices in Australia whereas health Canada regulates medical devices in Canada. Registration of medical devices in Australia & Canada is also included along with its regulatory requirements. While manufacturing of medical devices clinical investigation and clinical evaluation are important to check safety and effectiveness of device and after release of device in market adverse event reporting is also important to determine cause of adverse event which has occurred and can cause serious health effects. Labels are necessary on medical devices as it provides information to the consumers about product. Instruction manuals and other things can also be given with medical device so that the device is handled properly. The barcodes can be placed on the labels so that the device can be tracked easily if any adverse event takes place.
Thus, as the title suggests it’s a comparative study of medical device in Australia & Canada, we have differentiated points from guidelines which are slightly different in both countries. Case studies included also gives us idea about the adverse event which has occurred in recent years related to medical devices & also have added some recent updates related to medical devices in both countries.

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How to Cite
Shah, K. M. ., Chavan, R. V. ., Narang, A. P. ., Pawar, P. S. ., Kashid, G. A. ., Menon, G. ., & C. Sutar, R. . (2023). Comparative Study on Regulatory Requirements and Approval of Medical Devices in Australia & Canada. Journal of Coastal Life Medicine, 11(1), 1559–1580. Retrieved from


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