Medical Device Regulations: A Current Perspective

Abstract

There has been an upsurge in the number, diversity, and intricacy of medical devices in last two decades. Regulation of these devices has also advanced due to the requirement for a steady regulatory perspective. Various regulations of medical devices across major economies of the world were reviewed and then other pertinent issues of medical device regulations were discussed. The regulatory guidelines for medical devices in various countries which include United States, Europe, Japan, India, Brazil Japan, Australia etc. were reviewed. The need for harmonization of the device regulations and other regulatory issues were also assessed. Since the early 1980s, the regulatory paradigm for medical devices has changed exceptionally. Currently there are many countries which have enforced medical device regulations. Now with the availability of different regulations of the countries or region on medical devices, there is a need to harmonize regulations in order to curtail regulatory hurdles and expedite access to high quality, safe and efficacious medical devices. Most countries are trying to harmonize the regulatory guidelines for medical devices through their participation in Global Harmonization Task Force (GHTF). Harmonized regulation of medical device will lead to the availability of quality product. Key words: Medical device, Medical device recalls, Food drug and cosmetic act, Clinical trial, Humanitarian device exemption.