Global scenario of Medical Device vigilance system

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


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


Download data is not yet available.


1. Gupta P, Janodia DM, Jagadish PC and Udupa N. Medical Device vigilance system India, US, UK and Australia. NCBI [Internet]. 2010 Nov 22. [cited 2020 Jan 15]; Vol.3. Available from:
2. WHO. Medical device regulations global overview and guiding principles [Internet]. WHO [cited 2020 Jan 8]. Available from:
3. CDSCO. Indian Pharmacopoeia Commission. A guidance document for medical devices [Internet]. CDSCO; 2018 Jan [cited 2020 Jan 02]. Available from:
4. Kumar P, Singh GN and Kaur I. Materiovigilance Programme of India (MvPI).A step towards patient safety for medical devices. European journal of biomedical and pharmaceutical science [Internet]. 2016 [cited 2020 Jan 18]; Vol 3. Available from:
5. FDA.FDA regulation of Medical Devices. Congressional research service report [Internet]. FDA; 2016 Sept 14 [cited 2020 Jan 20]. Available from:
6. FDA. Medical device reporting (MDR): How to report medical device problems [Internet]. WHO; 2019 Jul [cited 2020 Jan 12]. Available from:
7. Langen J. Medical device reporting. Slide share Elsevier [Internet]. 2016 Sept [cited 2020 Jan 13]. Available from:
8. FDA. Department of Health and Human Services. Federal Register [Internet]. FDA; 2014 Feb 14 [cited 2020 Jan 16]; Vol. 79. Available from:
9. FDA. Mandatory Reporting Requirements: Manufacturers, Importers and Device User Facilities. [Internet]. FDA; 2019 May [cited 2020 Jan 16]. Available from:
10. FDA. Medical Device Tracking [Internet]. FDA; 2014 Mar [cited 2020 Jan 12]. Available from:
11. FDA. eMDR- Electronic medical device reporting [Internet]. FDA; 2018 Sept [cited 2020 Jan 12]. Available from:
614 Views | 306 Downloads
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.

Most read articles by the same author(s)

1 2 > >>