To improve patient safety and welfare of Indian population by monitoring adverse events related to medical devices and thereby reducing the risk associated with use of medical devices.
Safeguard the health of Indian population by ensuring that the benefits of use of medical devices outweigh the risks associated with its use.
Ministry of Health & Family Welfare, Government of India approved and commenced the Materiovigilance Programme of India (MvPI) in the country with the sole objective of monitoring the safety and ensuring quality of medical devices used in the country.
The MvPI was formally launched at the Indian Pharmacopeia Commission (IPC), Ghaziabad by the Drugs Controller General India (DCGI) on July 06, 2015. Indian Pharmacopoeia Commission (IPC) is an autonomous institution of the Ministry of Health & Family welfare and also functions as the National Coordination Centre (NCC) for the Materiovigilance Programme of India. Sree Chitra Tirunal Institute of Medical Sciences & Technology (SCTIMST), Thiruvananthapuram functions as a National Collaborating Centre for the MvPI. Technical support for the programme is being provided by Healthcare Technology Division, National Health System Resource Centre (NHSRC), New Delhi which is also a WHO collaborating Centre for priority medical devices and health technology policy.
MvPI program aims to promote and facilitate adverse event reporting of medical devices and subsequently evaluating these events. The scientific and systematic evaluation of these medical device adverse events/reports foster monitoring trends for improving and protecting the health and safety of patients. The Medical Device Rules 2017, effective since January 2018, mandates reporting of all Medical Device Adverse Event Reporting in the country for ensuring patient safety.
Currently there is low awareness of the health facilities regarding the MvPI programme and its reporting mechanism, which needs to be developed further in active mode to address public health concerns related to Medical Devices.
Medical Device Adverse Event Monitoring Centres (MDMCs) have been established to create awareness about the programme and enhance the quality of reporting. Under MvPI a total of 174 MDMCs have been identified in the country to report the adverse events associated with the use of medical devices, purely on voluntary basis. A standard reporting format called ‘Medical Device Adverse Event Reporting Form’ has been developed by IPC for collecting and monitoring adverse events associated with medical devices and IVDs.
Role of NHSRC:
- Healthcare Technology Division, NHSRC act as a technical support partner for MvPI
- NHSRC provides technical support on the activities of National collaboration centre Sree Chitra Tirunal Institute of Medical Sciences & Technology, (SCTIMST), Thiruvananthapuram and National coordination centre Indian Pharmacopoeia Commission (IPC) including trainings
- Preparation of standard operating procedures, guidance documents, training manuals etc
- Provide technical support on recruitment guidelines for various positions under MvPI
- Provide platform for achieving awareness among States/Uts for encouraging adverse event reporting
Modalities for reporting adverse events associated with medical device under MvPI: