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

Abstract

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

Downloads

Download data is not yet available.

References

1. Aliouche H. What are Medical Devices? [Internet]. UK: News-Medical; 2023 Apr 6 [cited 2023 Sep 30]. Available from:
https://www.news-medical.net/health/What-are-Medical-Devices.aspx
2. Medical Devices. [Internet]. Pan American Health Organization (PAHO) [cited 2023 Sep 30]. Available from: https://www.paho.org/en/topics/medical-devices
3. Medical devices [Internet]. Switzerland: World Health Organization [cited 2023 Sep 30]. Available from:
https://www.who.int/health-topics/medical-devices#tab=tab_1
4. Dove Jociute. The top 10 medical device companies in the world in 2023[Internet]. 2023 oct 9 [cited 2023 Oct 30]. Available from:
https://www.proclinical.com/blogs/2022-9/the-top-10-medical-device-companies-in-the-world-in-2022
5. Top 10 Medical Device Companies in the World in 2022[Internet]. breaking into device [cited 2023 Sep 30]. Available from:
https://www.breakingintodevice.com/blogs/medical-sales/top-medical-device-2022
6. Government of Canada [Internet]. Canada.ca link; 2020 Jan 27 [cited 2023 Sep 30]. Available from:
https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/about-medical-devices.html
7. Zhou K. The evolution of Canada’s medical device regulatory framework [Internet]. RF Quarterly. 2023;3(2):2023 June 28[cited 2023 Sep 30]. Available from:
https://www.raps.org/News-and-Articles/News-Articles/2023/6/The-evolution-of-Canada%E2%80%99s-medical-device-regulator
8. Patil M, Kothari l, mundada A. An Overview of the New Drug Submission and Approval Process for Canada. National journal of innovative research in technology [Internet]. 2023 Jul [cited 2023 Sep 30] 3;10(2):310-315. Available from:
https://www.ijirt.org/master/publishedpaper/IJIRT161005_PAPER.pdf
9. Legislation and Guidelines - Medical devices [Internet]. Canada: 2011 April 12 [cited 2023 Oct 1]. Available from:
https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/legislation-guidelines.html
10. Robert F.9 Ways Canadian Medical Device Regulations Differ from the US [Internet]. Canada: 2019 July 30 [cited 2023 Oct 1]. Available from:
https://www.qualio.com/blog/canadian-medical-device-regulations
11. Health Canada Medical Device Classification Consulting [Internet]. emergobyul link; 2023 [cited 2023 Oct 1]. Available from:
https://www.emergobyul.com/services/health-canada-medical-device-classification-consulting
12. Canadian Medical Device Classifications [Internet]. Vantagebiotrials link; 2023 Oct 24 [cited 2023 Oct 1]. Available from:
https://vantagebiotrials.com/class-ii-iv-medical-device-investigational-testing-in-canada/
13. Fees for examining a license application, amendment application for license or amendment to authorization, for medical devices [Internet]. Canada.ca link; 2023 April 01 [cited 2023 Oct 1]. Available from:
https://www.canada.ca/en/health-canada/services/drugs-health-products/funding-fees/fees-respect-human-drugs-medical-devices/medical-device-licence-application-review-funding-fees-drugs-health-products.html
14. Health Canada Approval Process for Medical Devices: Step-by-Step Guide[Internet]. Canada: 2023 [cited 2023 Oct 2]. Available from:
https://www.joharidigital.com/medical-device-registration-in-canada/
15. Health Canada Registration Process [Internet]. techlinkinternational. Commlink; 2023 [cited 2023 Oct 2]. Available from:
https://www.techlinkinternational.com/health-canada-approval-process/health-canada-registration-process
16. Medical Device Registration in Canada [Internet]. Italy: thema-med.com link; 2023 [cited 2023 Oct 2]. Available from:
https://www.thema-med.com/en/medical-device-registration-in-canada/
17. Canada Medical Device Regulations [Internet]. Holcombe Blvd: regdesk.co link; 2019 [cited 2023 Oct 2]. Available from:
https://www.regdesk.co/resource-library/canada/
18. Swetha N, Reddy D, Nagabhushanam M, Brahmaiah B, Ramakrishna G. Approval Process and Registration Process of Medical Devices in US, Canada And India. Indo American journal of pharmaceutical science [Internet]. Nov 2019 [cited 2023 Oct 2];06 (11):14301-14309. Available from:
http://doi.org/10.5281/zenodo.3531735
19. Medical Devices Making in India - A Leap for Indian Healthcare [Internet]. India: health care federation of India; 2016 Mar. [cited 2023 Oct 3]. Available from:
https://www2.deloitte.com/content/dam/Deloitte/in/Documents/life-sciences-health-care/in-lshc-medical-devices-making-in-india-noexp.pdf
20. Medical Devices in India [Internet]. Delhi: drishtiias.com link; 2018 [cited 2023 Oct 3]. Available from:
https://www.drishtiias.com/to-the-points/Paper2/medical-devices-in-india-1
21. Pandey A, Aswani H. India: Medical Devices: Compliances And Regulations In India [Internet]. mondaq; 2021 Dec 21 [cited2023 Oct 3]. Available from:
https://www.mondaq.com/india/life-sciences-biotechnology--nanotechnology/1143212/medical-devices-compliances-and-regulations-in-india#:~:text=The%20Drugs%20and%20Cosmetics%20Act,%22MDR%22)%20were%20drafted
22. Reddy H. Medical device regulatory priorities in India [Internet] : MED device online; 2018 May 12[cited2023 Oct 3].Available from:
https://www.meddeviceonline.com/doc/medical-devices-regulatory-priorities-in-india-0001
23. Targhotra M, Aggarwal G, Popli H, Gupta M. Regulatory aspects of medical device in India. International journal of drug delivery [Internet].2022 Oct [cited 2023 Oct 3] 9(2):18-27. Available from:
https://www.researchgate.net/publication/324839049_Regulatory_aspects_of_medical_devices_in_India
24. CDSCO Registration in India for Medical Devices / IVD / Cosmetics [Internet]. copbiz [cited 2023 Oct 03].Available from:
https://corpbiz.io/lp/cdsco-registration-for-medical?utm_source=google&utm_medium=ppc&utm_campaign=cdsco_registration&gclid=Cj0KCQjw1OmoBhDXARIsAAAYGSGlofxP2VqTWwY7yzgHH6r44VgvhAfzHnIYsZfqQNTZxrLPe91BCW0aArhGEALw_wcB
25. Step by step process to register your medical device in India[Internet]. Chennai: modula health tech [cited 2023 Oct 4]. Available from:
https://morulaa.com/medical-device/step-by-step-process-to-register-your-medical-device-in-india/
26. Medical device registration in India [Internet]. Singapore: Asia actual [cited 2023 Oct 4]. Available from:
https://asiaactual.com/india/medical-device-registration/
27. Pandey A, Aswani H.India: Medical Devices: Compliances And Regulations In India [Internet]. mondaq; 2021 Dec 21[cited 2023 Oct 4] Available from:
https://www.mondaq.com/india/life-sciences-biotechnology--nanotechnology/1143212/medical-devices-compliances-and-regulations-in-india#:~:text=The%20Drugs%20and%20Cosmetics%20Act,%22MDR%22)%20were%20drafted
28. Medical Device Registration in India for Foreign Manufactures [Internet]. freyer [cited 2023 Oct 4]. Available from:
https://www.freyrsolutions.com/infographics/medical-device-registration-in-india-for-foreign-manufactures
29. Evangeline L, Nagabhushanam M, Reddy D, Brahmaiah B, Ramakrishna.G. Registration and approval process of medical devices in India and Singapore.Indo American Journal Of pharmaceutical Sciences [Internet]. 2019 Nov. [cited 2023 Oct 4];06 (11), 14293-14300. Available from: https://iajps.com/pdf/november2019/48.IAJPS48112019.pdf
30. Pawar K,Gore R, Palekar S. A Review on Approval Process and Regulation of Medical Devices as per US FDA and CDSCO. International journal of drug regulatory affairs [Internet]. 2023 Mar 15 [cited 2023 Oct 4]; 11(1):61-70. Available from:
https://www.researchgate.net/publication/370019210_A_Review_on_Approval_Process_and_Regulation_of_Medical_Devices_as_per_US_FDA_and_CDSCO
31. Radhadevi N, Balamuralidhara V, Kumar T, Ravi V, Regulatory guidelines for medical devices in India: An overview. Asian journal of pharmaceutics [Internet]. 2012 Jan- Mar [cited 2023 Oct 4]; 6:10-7. Available from:
https://www.asiapharmaceutics.info/index.php/ajp/article/view/68/34
32. Registration of Medical Devices in India [Internet].Chennai: modula health tech [cited 2023 Oct 4]. Available from:
https://morulaa.com/medical-device/registration-of-medical-devices-india/
33. Naga S, Venkateswara R, Prasanthi N. A Comparative Study of Medical Devices and Their Regulations in US, EU, India, And China. Asian J Pharm Clin Res [Internet]. 2012 Oct 17 [cited 2023 Oct 4]; 16(3): 6-14. Available from:
https://journals.innovareacademics.in/index.php/ajpcr/article/view/46624/27817
34. Guidance document on application for grant of License in Form-28 for manufacture of Medical Devices in India under CLAA Scheme [Internet]. India: CDSCO; 2013 Jan 1[cited 2023 Oct 4]. Available from:
http://www.msk.nclinnovations.org/medregulations/v1/html/Guidance/Guidance_Form%2028%20Manufacturing%20License.pdf
35. Venugopal N, Sella Senthil M, Gowthamaraj K, Arun R. Advancements in Regulatory Framework for Medical Device Regulations in India.International Journal of Pharmaceutical Research [Internet]. 2020 Aug [cited 2023 Oct 5]. Available from:
https://www.researchgate.net/publication/343738548_Advancements_in_Regulatory_Framework_For_Medical_Device_Regulations_In_India
36. Opportunities in the medical devices sector in India [Internet]. Pmlive link: 2013 Apr. 3rd [cited 2023 Oct 5]. Available from:
https://www.pmlive.com/pharma_intelligence/opportunities_in_the_medical_devices_sector_in_india_469843?SQ_DESIGN_NAME=2&
37. Pabbati Sanjana, Hira K, Begum SA; Medical Device and their Approval Procedure in India, IJDRA[Internet]. 2016 [cited 2023 Oct 5]; 4(3), 19-29. Available from:
https://ijdra.com/index.php/journal/article/view/186/103
38. Medical Device Industry in India [Internet]. Ahmedabad: Medical Device Industry in India; 2021 July [cited 2023 Oct 6]. Available from:
https://www.ikonmarket.com/market-insights/medical-device-industry-india.html
39. Rao RJ. Sutar GR. Evolution of Medical Device Sector in India and Comparison of Registration Processes of Medical Devices in India with Countries like China, Australia, U.S. and Europe. Pharmaceutical Drug Regulatory Affairs Journal [Internet]. 2021 Dec 31 [cited 2023 Oct 6]; 4(1): 000127. Available from:
https://medwinpublishers.com/PDRAJ/evolution-of-medical-device-sector-in-india-and-comparison-of-registration-processes-of-medical-devices-in-india-with-countries-like-china-australia-u-s-and-europe.pdf
40. Regulatory Agencies [Internet]. Canada: government of Canada;2004 Oct 1 [cited 2023 Oct 6]. Available from:
https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/international/regulatory-agencies.html
41. Lentz B. Canada medical device regulation [Internet]. med tec; 2023 Jul 12[cited 2023 Oct 6]. Available from:
https://www.rimsys.io/blog/canada-medical-deviceregulations#:~:text=The%20regulation%20of%20medical%20devices%20in%20Canada%20is%20driven%20by,SOR%2F98%2D282
42. About medical device [Internet]. Canada: government of Canada; 2020 Jan 27[cited 2023 Oct 6]. Available from:
https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/about-medical-devices.html
43. Quality Systems ISO 1348542 [Internet]. Canada: government of Canada; 2019 Jan 2 [cited 2023 Oct 7]. Available from:
https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/quality-systems-13485.html
44. Filing submissions electronically [Internet]. Canada: government of Canada; 2023 Jun 16 [cited 2023 Oct 7]. Available from:
https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/filing-submissions-electronically.html
45. Language requirements — Skilled immigrants (Express Entry) [Internet]. Canada: government of Canada;2023 sep 15 [cited 2023 Oct 7]. Available from:
https://www.canada.ca/en/immigration-refugees-citizenship/services/immigrate-canada/express-entry/documents/language-requirements.html
46. Guidance on clinical evidence requirements for medical devices: Overview [Internet]. Canada: government of Canada;2023 Apr 4 [cited 2023 Oct 7]. Available from:
https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/clinical-evidence-requirements-medical-devices.html
47. Medical Device Registration in Canada [Internet]. OMC medical regulatory services [cited 2023 Oct 7]. Available from:
https://omcmedical.com/medical-device-registration-in-canada/
48. How Health Canada inspects medical device establishments: About inspections [Internet]. Canada: government of Canada;2022 Jun 17 [cited 2023 Oct 7]. Available from:
https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/information-health-product/medical-devices/inspects-medical-device-establishments-0064/about-inspections.html
Statistics
57 Views | 70 Downloads
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.