Regulatory requirements for Medical Device Registration in Kingdom of Saudi Arabia, US and European Union

  • Rajveer Bhaskar
  • Monika Ola
  • Subhash Singh Saharan
  • Vishal Nikam R. C. Patel Institute of Pharmaceutical Education and Research, Shirpur. Dist. Dhule

Abstract

Understanding and observing regulatory norms is essential for the development and commercialization of medical devices. To assure the operation, safety, and effectiveness of medical devices while minimizing adverse effects, strict regulatory criteria are required as their use grows. The ability to offer the essential direction for proper registration by pertinent authorities, manufacturers, and importers has been made possible by recent recommendations. Medical device rules are now being implemented in many nations. Converging rules are essential to reduce regulatory barriers and speed up access to high-quality, secure, and effective medical devices since different countries and regions have different laws governing medical devices. The Global Harmonisation Task Force (GHTF), which strives to harmonise medical device regulatory regulations, is comprised of the majority of nations. Medical device regulations that are more uniform will make high-quality products more widely available. This article discusses the definition of a medical device in each of these areas, and it does so in the order of their proportion of the global market share. In this article, we looked at how major economies throughout the world regulate medical devices. This article's objective is to give a thorough review of the legal systems that govern the registration of medical devices in the European Union, the United States, and the Kingdom of Saudi Arabia. The current article discusses the classification of medical devices in the Kingdom of Saudi Arabia, the United States, and the European Union, as well as the registration procedure for medical devices.

Keywords: Global Harmonisation Task Force (GHTF), Saudi Food and Drug Authority (SFDA), United States Food and drug Administration (USFDA), European Commission, Medical devices

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How to Cite
Bhaskar, R., M. Ola, S. S. Saharan, and V. Nikam. “Regulatory Requirements for Medical Device Registration in Kingdom of Saudi Arabia, US and European Union”. International Journal of Drug Regulatory Affairs, Vol. 11, no. 2, June 2023, pp. 75-85, doi:10.22270/ijdra.v11i2.605.