Medical device vigilance system

  • Riya Patel Gujarat
  • Bhumika Maheriya Gujarat


The medical device vigilance is the synchronized system of to identify, to compile, to notify and to analyse of any adverse event which are connected with the use of medical devices and to defend the health of   patient and also preventing relapses. In many nations, post-marketing surveillance of medical devices has begun but is not yet as established or robust as that for medicines. In USA a program has started under the name of Medical Device Reporting (MDR) and in 2015 India also introduced the Materiovigilance program by DCGI at the Indian Pharmacopoeia Commission (IPC) in Ghaziabad. Main benefit of an efficient system such as medical device vigilance in reporting the risks and safety crises of medical devices has become gradually evident in recent years. Safety issues of medical devices tend to quickly gain global significance. The speed of information spreads in the modern world means that concerns about the safety of medical devices are no longer limited to individual countries. Around the world, to improve the standard of medical devices, several measures are being taken to provide greater patient safety. The main goal of the concept turns out to be to accurately ensure the safety of the patient, as well as provided that the necessary guidance for both producers and expert authorities that allows them to monitor cases reliably and appropriately.

Keywords: Materiovigilance, Medical Device Reporting (MDR), CDSCO, adverse event, surveillance, medical device


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Author Biography

Bhumika Maheriya, Gujarat

M.Pharm, PG Diploma in Intellectual property rights

Assistant professor at Graduate School of Pharmacy-Gujarat Technological University


1. Hoda F, Verma R, Arshad M, Siddiqui AN, Khan MA, Akhtar M. Materiovigilance: Concept, structure and emerging perspective for patient’s safety in India. Drug Res (Stuttg). 2020 Sep; 70(9):429-36.
2. Gupta SK. Medical Device regulations: A current perspective. J Young Pharm. 2016 Jan; 8(1):6-11.
3. Jefferys DB. The regulation of medical devices and the role of the medical device’s agency. Br J Clin Pharmacol. 2001 Sep; 52(3):229-35.
4. Rani S, Singh K. Materiovigilance: an emerging discipline. Inter J Sci Res. 2018 June; 7(6):15-6.
5. Masurkar P. A need of better pharmacovigilance system in India. Asian J Pharm Clin Res. 2017 Jan; 10(1):22-4.
6. Materiovigilance Programme of India (MvPI) - Indian Pharmacopoeia Commission [Internet].IPC; 2020 Jul 22 [cited 2021 Jan 29]. Available from:
7. Kalaiselvan V, Kumar P, Mishra P, Singh GN. System of adverse drug reactions reporting: what, where, how, and whom to report? Indian J Crit Care Med. 2015 Sep; 19(9):564-6
8. GHTF. Comparison of the Device Adverse Reporting Systems in USA, Europe, Australia, Canada and Japan. Global Harmonization Task Force; 2002
9. Golder S, Wright K, Rodgers M. Failure or success of search strategies to identify adverse effects of medical devices: a feasibility study using a systematic review. Syst Rev. 2014 Oct; 3(8):1-6
10. Kumar P, Kalaiselvan V, Kaur I, Thota P, Singh GN. Materiovigilance program of India (Mvpi): A step towards patient safety for medical devices. Eur J Bio and Pha Sci. 2016 Nov; 3(12):497-501.
11. Making medical device vigilance more effective. [Internet]. MHRA; 2007 [cited 2021 Feb 15]. Available from:
12. Judith A. Johnson. FDA regulation of medical device. Congressional Research Service; 2016
13. Pane J, Francisca RDC, Verhamme KMC, Orozco M, Viroux H, Rebollo I, et al. EU postmarket surveillance plans for medical devices. Pharmacoepidemiol Drug Saf. 2019 Sep; 28(9):1155-65.
14. Georgette Lalis. Medical Devices Post Market Surveillance: Global Guidance for Adverse Event Reporting for Medical Devices. Global Harmonization Task Force; 2006
15. Stout L. GHTF SG1 - Definition of the Term Medical Device. J Corp Law. 2014 Sep; 1(5):526-44.
16. Shukla S, Gupta M, Pandit S, Thomson M, Shivhare A, Kalaiselvan V. Implementation of adverse event reporting for medical devices, India. Bull World Health Organ. 2020 Mar; 98(3):206-11.
17. U.S. Food & Drug Administration. Recalls, Collections and Removals (Devices) [Internet]. FDA; 2020 Sept 29 [cited 2021 Feb 13]. Available from:
18. USFDA. Regulatory procedures manual, chapter 7 recall procedures. 2020; 8:61-67
19. Medicine and healthcare products regulatory agency. Medical devices: guidance for manufacturer on vigilance [Internet]. [cited 2021 Feb 22]. Available from:
20. The Medical Devices Regulations 2002 [Internet].; 2002 [cited 2021 Feb 22]. Available from:
21. USFDA. Medical Device Tracking Guidance for Industry and Food and Drug Administration Staff. Center for Device and Radiological Health; 2014
22. USFDA. Medical device tracking [Internet]. FDA; 2018 Sept 27 [cited 2021 Mar 29]. Available from:
23. Terms of Reference Research Associates – Materiovigilance Program of India (MvPI). National Health Systems Resource Centre, MoHFW, Government of India [Internet]. [cited 2021 Feb 25]. Available from:
24. Postmarket 522 Surveillance Studies. [Internet].; 2021 [cited 2021 Jan 29]. Available from:
25. Chauhan P, Zarreen A, Iqubal MK. Current status of materiovigilance globally- an utter overview with clinical case perusal. Int J Pharm Pharm Sci. 2019 Sep; 11(10):1-7
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How to Cite
Patel, R., and Bhumika Maheriya. “Medical Device Vigilance System”. International Journal of Drug Regulatory Affairs, Vol. 9, no. 3, Sept. 2021, pp. 1-8, doi:10.22270/ijdra.v9i3.475.