Bull World Health Organ 2020;98:206–211 | doi: http://dx.doi.org/10.2471/BLT.19.232785 Lessons from the feld 206 Introduction Rapid growth in the use of medical devices in health-care settings has been enabled by technological advancements, such as drug–device combination products, automation and wireless technology, and advanced clinical application of devices. 1 The estimation of the global market for medi- cal devices increased from 260 billion United States dollars (US$) in 2006 to over US$ 380 billion in 2016. 2 The quality of devices, however, can vary and even the best-designed products can fail in clinical practice. Post-market surveil- lance is therefore essential to ensure the quality and evaluate the safety and performance of medical devices. Despite the importance placed on surveillance of drug safety, the need for better monitoring of medical device-associated adverse events receives less attention. A well-structured vigilance system is the backbone of a robust regulatory framework to ensure the quality and pro- mote the safe use of medical devices. Te regulation of medical devices, however, is a complex and evolving area that is ofen complicated by legal technicalities. For example, legal termi- nologies are sometimes non-uniform even within the same regulatory system. Regulations may difer from one country to another. Here we report our experiences with the design of a system to monitor the safety of medical devices in India. Local setting Earlier, medical devices were regulated under the Indian Drugs and Cosmetics Act and no systematic structure was in place to collate adverse events associated with medical devices. Several reports 3 of deaths and hospitalization due to faulty hip implants, cardiac stents and poor-quality devices, drew attention to the need for a parallel system for surveillance of medical devices. In July 2015, the Indian health ministry ap- proved the establishment of the materiovigilance programme, with the Indian Pharmacopoeia Commission as the national coordinating centre. In 2017, the government of India issued the Medical Devices Rules 2017 for regulating medical devices used throughout the country. 4 Te rules came into efect on 1 January 2018. Approach Te materiovigilance programme aims to enable data collec- tion and evaluation in a systematic manner so that regulatory decisions and recommendations on the safe use of medical devices in India can be evidence-based. Te programme also aims to create awareness among stakeholders about the importance of medical device adverse event reporting and to monitor the beneft–risk profle of medical devices. Te Central Drugs Standard Control Organization, under the directorate general of health services of the health ministry is the national regulatory authority responsible for approval a Medical Device & Materiovigilance Programme of India, Indian Pharmacopoeia Commission, Ministry of Health & Family Welfare, Government of India, Sector-23, Raj Nagar, Ghaziabad-201002, Uttar Pradesh, India. b Ofce of the WHO Representative to India, New Delhi, India. c Indian Pharmacopoeia Commission, Ministry of Health & Family Welfare, Uttar Pradesh, India. Correspondence to Shatrunajay Shukla (email: shatrunjay.iitr@gmail.com). (Submitted: 8 March 2019 – Revised version received: 2 October 2019 – Accepted: 25 October 2019 – Published online: 18 November 2019 ) Implementation of adverse event reporting for medical devices, India Shatrunajay Shukla, a Madhur Gupta, b Sabitri Pandit, a Milu Thomson, a Abhimanyu Shivhare, a Vivekanandan Kalaiselvan a & Gyanendra Nath Singh c Problem Rapid growth in the use of medical devices has drawn attention to gaps in the systematic monitoring of medical device-associated adverse events in India. Approach Implementation of national regulations on medical devices started in January 2018. Supported by a nationwide network of monitoring centres, the Indian Pharmacopoeia Commission coordinates adverse event reports from manufacturers, legal representatives and patients or users. The commission follows-up and reviews reports with subject expert groups and sends recommendations on necessary action to the national regulatory authority. Local setting Before 2015, no systematic structure was in place to collate adverse events associated with medical devices. Several reports of deaths and hospitalization due to faulty hip implants, cardiac stents and poor-quality devices prompted the health ministry to launch the materiovigilance programme. Relevant changes From July 2015 to October 2019, the commission received 1931 adverse event reports, mostly from marketing authorization holders; 1277 were serious events. Reporting increased markedly after 2017. Cardiac stents were the most reported device (926 events; 47.95%). To encourage a culture of reporting, the commission has raised awareness about the programme among stakeholders, developed user-friendly reporting tools and guidelines, and conducted training for hospital personnel on medical device adverse event reporting. Lessons learnt Regular training to stakeholders develops a sense of responsibility towards reporting medical device adverse events and ensures quality data reporting. Reporters must be assured that reporting adverse events does not have any legal implications for them and given acknowledgement of their role in high-quality device associated adverse event reporting. Lessons from the field