The Materiovigilance Program of India (MvPI), launched by the Ministry of Health & Family Welfare, Government of India has released a circular to minimize adverse effects of medical devices and Iin vitro diagnostic medical devices. Adverse effects or risks related to medical devices and their use by healthcare professionals must be recorded. All Medical Devices including in vitro medical device license holders are suggested to use MvPI platform to report adverse effects.
Medical devices including in vitro diagnostic medical devices come under the Drugs & Cosmetics Act, 1940 and Medical device rules, 2017. A license/approval is required for the import/manufacture for marketing of these medical devices. The license is issued with the condition to comply with the Quality management system and the Post-market surveillance (PMS) of medical devices. Cause of adverse effects or risks related to the use of medical devices and in vitro diagnostics by healthcare professionals will be monitored, analyzed, and recorded. Regulatory bodies will be suggested when appropriate action is needed. Thus, all the medical devices including In-vitro diagnostics license holders are instructed to use the MvPI platform to report any adverse effects in a timely fashion. These initiatives are being taken by the MvPI to safeguard patient health and minimize medical device risks.