Materiovigilance Programme of India (MvPI) is launched.

Materiovigilance Programme of India (MvPI) to monitor the safety of medical devices in the country has been approved for the commencement by the Ministry of Health & Family Welfare, Govt. of India.

The MvPI is formally launched on 06th July 2015 at IPC, Ghaziabad by DCG(I).

The Indian Pharmacopoeia Commission functions as National Coordination Centre for MvPI. Sree Chitra Tirunal Institute of Medical Sciences & Technology (SCTIMST) will be function as National Collaborating Centre. National Health Systems Resource Centre (NHSRC) under MoHFW, Govt. of India working as technical support and resource centre.

 

mvpi

The MvPI is meant to enable safety data collection in a systematic manner so that regulatory decisions to be taken and recommendations suggested for safe use of medical devices could be based on data generated in India.

Goal

To ensure that the benefits of use of medical devices outweighs the risk and thus safeguard the health of the Indian population.

Objectives

 To monitor Medical Devices Associated Adverse Events (MDAEs) in Indian Population.

 To create awareness amongst healthcare professionals about the importance of MDAE reporting in India.

 To evaluate risk benefit profile of Medical Devices.

 Generate independent evidence based recommendations on the safety of Medical Devices.

 Support CDSCO for formulating safety related regulatory decisions pertaining to Medical Devices.

 Communicate findings with all key stakeholders eg. – manufactures, regulators, prescribers.