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Clinical Evaluation & Post Marketing Surveillance Of Medical Devices In India: A Regulatory Look
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| Author:
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SANHITA SINGHA ROY, BALAMURALIDHARA V, SWATHI K C, M.P.GOWRAV
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| Abstract:
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Medical devices are generally utilized in the medicinal services segment & those produced from the pharmaceutical business. The Government of India has occasionally turned out with specific rules, are trailed by the organizations that are producing medical devices. There are a few difficulties which have to do with the medical devices. Medical devices structured from producers in response to requests and desires for specialists. They are then assessed by specialists and are utilized in patients. Stage I preliminaries are impractical for them as they can't be tried on solid volunteers. Unfriendly Medication Responses are not identified in medical devices as effectively concerning drugs. There are no different guidelines (apart from Schedule M III of Drugs and Cosmetics Act) for Medical Devices in India before 2017.The Medical Device Rules 2017, provides information about the various requirements of clinical evaluation of medical devices along with the materiovigilance programme of India that is designed for the post marketing surveillance. This article focuses on the requirements of various documents for the clinical evaluation of medical devices in India. It also elaborates upon the post marketing surveillance activities carried out for medical devices, including its scope and a flowchart that demonstrates the flow of vigilance information.
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| Keyword:
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Medical devices, The Medical Device Rules, 2017, post marketing surveillance
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| EOI:
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| DOI:
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https://doi.org/10.31838/ijpr/2020.SP1.057
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| Download:
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