Abstract
There has been an escalation in the number, diversity, and complexity of
medical devices. Regulation of these devices has also advanced due to the
requirement of better regulatory perspective induced due to elevation in the
number of adverse events associated with medical devices. All over the
globe, various measures are undertaken to provide better safety to the
patients along with attempts to improve the standard of medical devices. The
initial and ultimate objective of the concept happens to be unfailingly to
ensure patient safety as well as impart required guidance for both
manufacturers and adept authorities enabling them to superintend cases
coherently and appropriately. Materiovigilance programme of India (MvPI) was
launched by the Drug Controller General of India at the Indian Pharmacopoeia
commission (IPC) in Ghaziabad in 2015. The main purpose of this initiative
is to monitor adverse events associated with medical devices in order to
generate safety data, create awareness among the various stakeholders, and
prescribe best practices for patient safety. Whilst the reforms in
regulations have proposed policies and designs to elucidate, consolidate and
accelerate the processes involved in manufacturing and importing medical
devices to India, they consistently carry their challenges and limitations.
To eliminate such complications the guidelines and regulations are
anticipated to be implemented appropriately with the efficacious conclusion.
India has been evident in matching with advancements in the World Medical
Device regulation scenario, the current review at hand takes upon the
question of ‘how successful has it been so far’?
Key words
diagnostics - adverse drug reactions - drug regulation - drug research
