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Regulations of Medical Devices in Regulated Countries: A Comparative Review

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Abstract

The term “medical device” covers a vast range of equipment, from simple tongue depressors to hemodialysis machines. Like medicines and other health technologies, they are essential for patient care. With the increased use of medical devices, stringent regulatory standards are required to ensure that the devices are well studied, safe, and well tolerated. Recently, introduced guidelines and amendments in the laws of the US, Europe, and Canada provide adequate guidance for both manufacturers and competent authorities to prevent defects and performance failures efficiently and appropriately. A defective device may result in inaccurate patient results, leading to misdiagnosis, delays in treatment, adverse events, injuries, or even death. Therefore, a thorough review of the medical device before being released for use by the public and effective monitoring of the medical device once placed on the market are crucial.

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Authors and Affiliations

  1. Pharmaceutical Regulatory Affairs Group, Department of Pharmaceutics, JSS College of Pharmacy, JSS University, Nagar, Mysore, 570015, India

    G. V. S. S. N. Jyothi MPharm, M. P. Venkatesh MPharm, PhD & T. M. Pramod Kumar MPharm, PhD

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  1. G. V. S. S. N. Jyothi MPharm
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  2. M. P. Venkatesh MPharm, PhD
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  3. T. M. Pramod Kumar MPharm, PhD
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Correspondence to M. P. Venkatesh MPharm, PhD.

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Jyothi, G.V.S.S.N., Venkatesh, M.P. & Pramod Kumar, T.M. Regulations of Medical Devices in Regulated Countries: A Comparative Review. Ther Innov Regul Sci 47, 581–592 (2013). https://doi.org/10.1177/2168479013492735

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