COMPARATIVE STUDY ON CURRENT REGULATION OF MEDICAL DEVICES IN JAPAN AND RUSSIA

Title: COMPARATIVE STUDY ON CURRENT REGULATION OF MEDICAL DEVICES IN JAPAN AND RUSSIA

Author(s): Rashi Patel and J. Saminathan

ABSTRACT

Registration of medical devices has always been a complex, time-consuming, and expensive process. All medical devices and equipment have to go through a mandatory set of tests, even though the same tests have been performed during a process. Global Harmonization Task Force defines and classifies the Medical devices on basis of risk associated with it. In this article we will study about the regulations required for both the countries to register the medical device and there comparison. As one of the largest and most affluent aging populations in the world, Japan is well known, for its standards and regulations, especially for foreign companies and manufacturers. The lack of transparency with Russia’s regulatory system can confound foreign manufacturers who are used to approach countries with more established and transparent regulatory systems. The recommendation for both the authorities has discussed in the article.

Keywords: Medical Device, PMDA, RCB, Roszdravnadzor, Registration, Regulation.

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