MEDICAL DEVICE REGULATION IN US, EUROPE, CHINA AND INDIA

  • Ganesh GNK
  • Nishanthini B.
  • Lakshmi T. Vidhya

Abstract

Medical Device is an emerging market in last two decades since the use of medical device is escalating throughout the world. Millions of patients worldwide depend on Medical Device for the diagnosis & Management of diseases. Regulation of the Medical Device varies within the country are based on their own Regulatory bodies. In US Medical Devices are regulated by FDA- Centre for Devices & Radiological Health, in EU they are regulated by European Medical Agency, in China they are regulated by State Food & Drug Administration and in India they are regulated by Central Drug Standard Control Organization. Regulations of these countries and IMDRF, MDPWG were reviewed. Advantage of harmonizing regulations also reviewed.

Keywords: FDA, CDHR, 510(K) process, PMA, CE marking, notified bodies, CDSCO, SFDA, IMDRF.

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How to Cite
GNK, G., N. B., and L. T. Vidhya. “MEDICAL DEVICE REGULATION IN US, EUROPE, CHINA AND INDIA”. International Journal of Drug Regulatory Affairs, Vol. 5, no. 2, Feb. 2018, pp. 17-25, doi:10.22270/ijdra.v5i2.198.

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