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March 15, 2025International Journal of Drug Regulatory AffairsOpen Access

Comparative Study of Medical Device Regulation in US, EU and Canada

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Authors

JWJayesh V. WadgeNuclear Regulatory Authority of the Slovak RepublicSPSanjay B. PatilShri Jagdishprasad Jhabarmal Tibrewala University

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Implication

Comparative study reveals different regulatory approaches in US, EU, and Canada for medical devices, highlighting key compliance mechanisms.

Key Points

  • Canada requires Medical Device Licenses and Investigational Testing Authorization for clinical trials and compliance with regulations.
  • The FDA oversees device regulation in the US, utilizing processes like 510(k) notifications and Premarket Approval for device safety.
  • The European Union employs the Medical Device Regulation which mandates comprehensive clinical evaluations and post-market surveillance.
  • Key differences in regulatory frameworks impact how manufacturers navigate market access in the US, EU, and Canada.

Cite This Study

Wadge et al. (2025) studied this question.

synapsesocial.com/papers/68af453aad7bf08b1ead2a73https://doi.org/10.22270/ijdra.v13i1.735
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Also Consider

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  1. 1Regulatory Approaches to Medical Devices: A Comparison between the United States, European Union, and India2025 · 1 citations
  2. 2Clinical Investigations of High-Risk Medical Devices in India, Germany and Canada2025
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  4. 4The Registration of Medical Device in FDA, EU and CDSCO: Overview2024 · 5 citations
  5. 5Understanding medical device regulation2016 · 10 citations