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Abstract

A COMPARATIVE STUDY ON REGULATORY REQUIREMENT FOR REGISTRATION OF MEDICAL DEVICES IN US, EUROPE AND CANADA

S. Mounika*, M. V. Nagabhushanam, Y. Ratna Sindhu, T. Mohini, Brahmaiah Bonthagarala and G. Ramakrishna

Abstract

The medical device industry in the industry which deals the multiple types of the products covering with the wide range of the applications. As per the safety and effectiveness of the medical devices are important to the human health, the products must be managed by the strict regulations according to the different risk levels. The product life cycle regulatory system will includes the product design, manufacture, premarket gate keeping and the postmarket monitoring as the common framework for the regulations of the medical devices. However the variety and the innovativeness of the medical devices are challenging the present regulatory frameworks. Since, the competent authorities is responsible for the medical devices worldwide keep renewing their regulatory systems to ensure the safety and effectiveness of the medical devices in the United States, Europe and Canada with the particular focus on the updated regulatory changes in these countries and the current status of the global harmonization on the medical devices.

Keywords: Safety, Effectiveness, Regulatory reform, IMDRF, Harmonization.


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