A Review on Approval and Registration Process of Medical Devices in Canada and India

  • Gaurav V. Patil Department of Regulatory Affair snjb shriman sureshdada jain college of pharmacy neminagar chandwad
  • Ganesh D. Basarkar


A medical device is any device or material used to promote human health. Due to an increase in the prevalence of chronic diseases, irregular health examinations, and sedentary lifestyles, as well as an increase in cases of obesity, diabetes, neuro-based disorders, heart diseases, and chronic diseases linked to lifestyle disorders, the use of medical devices is increasing. There are many medical devices in use today, and different rules and regulations apply to their marketing in various nations. To be sold on the market, a medical device needs to have its marketing authorization granted by the appropriate country's regulatory organization. Medical device-based therapeutic therapy is offering technologically sophisticated alternatives for the management of a number of ailments. The ministry of health and family welfare as well as science and technology in India rely heavily on the CDSCO as their primary medical regulating body. This article has been produced to discuss how medical devices are approved and registered, as well as the recent market expansion. Medical equipment sales are strong but profitable in Canada. It has one-fifth the population of Brazil, yet spends nearly as much on healthcare every year. As a result, rules and regulations must be in place to oversee the sale of such products.  standardized medical equipment in order to facilitate their swift approval as well as the registration of medical devices, registration across all markets is crucial.

Keywords: Medical devices, Health Canada, organization Structure of health Canada, CDSCO, Drugs and cosmetics act 1940 and its rule 1945, medical device lifecycle, approval process


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How to Cite
Patil, G. V., and G. D. Basarkar. “A Review on Approval and Registration Process of Medical Devices in Canada and India”. International Journal of Drug Regulatory Affairs, Vol. 11, no. 4, Dec. 2023, pp. 39-51, doi:10.22270/ijdra.v11i4.631.