Department of Pharmacology, School of Pharmaceutical Education and Research, Jamia Hamdard, New Delhi, India.
Department of Pharmaceutical Medicine, School of Pharmaceutical Education and Research, Jamia Hamdard, New Delhi, India.
Drug Res (Stuttg). 2020 Sep;70(9):429-436. doi: 10.1055/a-1195-1945. Epub 2020 Aug 3.
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'?
医疗器械的数量、种类和复杂性不断增加。由于与医疗器械相关的不良事件数量增加，需要更好的监管视角，因此这些设备的监管也有所进步。在全球范围内，各国都采取了各种措施来提高患者安全性，并努力提高医疗器械的标准。该理念的最初和最终目标始终是确保患者安全，并为制造商和专业当局提供必要的指导，使他们能够连贯、恰当地监督案例。印度药品监管总局（DCGI）于 2015 年在印度药物标准局（IPC）在加济阿巴德启动了印度医疗器械警戒计划（MvPI）。该倡议的主要目的是监测与医疗器械相关的不良事件，以生成安全性数据，提高各利益相关者的认识，并为患者安全制定最佳实践。虽然监管改革提出了政策和设计，以阐明、整合和加快医疗器械在印度的制造和进口流程，但它们始终存在挑战和局限性。为了消除这些并发症，预计将适当实施指导方针和法规，以取得有效的结论。印度在与世界医疗器械监管环境的发展保持一致方面表现出色，目前正在审查“迄今为止它取得了多大的成功？”这一问题。
