Global scenario of Medical Device vigilance system

  • Suheta Tikoo M.Pharmacy (Drug Regulatory Affairs)
  • Vikesh Kumar Shukla

Abstract

Patient all over the world depend on wide array of medical devices for diagnosis and management of diseases. Medical devices are considered as crucial component for patient care. It is difficult to establish a global definition of medical devices, as different countries have numerous regulatory bodies overseeing the market of medical devices. As per Global Harmonization Task Force (GHTF) definition, the term medical devices means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent and calibrator, software, material or other similar or related article intended by the manufacturer to be used alone or in combination for human beings for diagnosis, prevention, monitoring, treatment or alleviation of disease. Pharmacovigilance system is a branch of pharmacological science dealing with reporting of adverse reaction events which are caused by medicines and medical devices. Adverse event can have a major effect on population and hence is one of the potential concerns of public health which requires continuous recording, evaluation and monitoring. To achieve uniformity among the national medical device regulatory systems and increase the access to safe, effective, and clinically beneficial medical technologies, the Global Harmonization Task Force (GHTF) was conceived in 1992 by five members: European Union, United States, Australia, Japan, and Canada. All regulated countries have clearly defined medical devices, as has the GHTF. Although GHTF has tried to achieve harmonization with respect to medical devices, some differences still exist in the national laws of the countries of GHTF. Further, regulated countries have classified medical devices on the basis of their associated risk. India is lagging behind in medical device regulations, although now it is moving towards harmonizing its medical device regulations with those of regulated countries, this study aims to identify vigilance system of medical devices in various countries.

Keywords: Medical devices, Vigilance, regulatory system, GHTF

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How to Cite
Tikoo, S., and V. K. Shukla. “Global Scenario of Medical Device Vigilance System”. International Journal of Drug Regulatory Affairs, Vol. 8, no. 1, Mar. 2020, pp. 36-43, doi:10.22270/ijdra.v8i1.381.

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