{"title":"Comparative Materiovigilance Program for US, Europe, Japan, India and Proposed Reporting Mechanism for Indian Scenario","authors":"Manvendra S. Teli, Vikas Jhawat","doi":"10.25258/ijpqa.14.3.12","DOIUrl":null,"url":null,"abstract":"Medical devices are thought to be a blessing for the healthcare system because they are tools that can save lives. Apart from therapeutic potential, these devices have lot of negative side effects. It took a strong cohort attentive system to control such negative impacts. As a result, materiovigilance was introduced. Materiovigilance is the investigation and monitoring of incidents brought on by the use of medical devices. It controls adverse events (AE) and brings about international harmony. These goals are kept in mind when the principles, viewpoints, and materiovigilance techniques in the USA, Europe, China, Japan, Australia, Canada, and India are contrasted. It is crucial to make this comparison to comprehend the shortcomings of the current regulatory frameworks in the nations described above. Additionally, it will give the regulatory authorities a complete picture so they can alter any existing legislation as necessary. In the present study, an ideal proposed model of medical devices for its approval has been explained easily","PeriodicalId":14260,"journal":{"name":"International Journal of Pharmaceutical Quality Assurance","volume":"14 1","pages":"0"},"PeriodicalIF":0.0000,"publicationDate":"2023-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Journal of Pharmaceutical Quality Assurance","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.25258/ijpqa.14.3.12","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"Pharmacology, Toxicology and Pharmaceutics","Score":null,"Total":0}
引用次数: 0
Abstract
Medical devices are thought to be a blessing for the healthcare system because they are tools that can save lives. Apart from therapeutic potential, these devices have lot of negative side effects. It took a strong cohort attentive system to control such negative impacts. As a result, materiovigilance was introduced. Materiovigilance is the investigation and monitoring of incidents brought on by the use of medical devices. It controls adverse events (AE) and brings about international harmony. These goals are kept in mind when the principles, viewpoints, and materiovigilance techniques in the USA, Europe, China, Japan, Australia, Canada, and India are contrasted. It is crucial to make this comparison to comprehend the shortcomings of the current regulatory frameworks in the nations described above. Additionally, it will give the regulatory authorities a complete picture so they can alter any existing legislation as necessary. In the present study, an ideal proposed model of medical devices for its approval has been explained easily
期刊介绍:
INTERNATIONAL JOURNAL OF PHARMACEUTICAL QUALITY ASSURANCE is a quarterly international journal publishing the finest peer-reviewed research in the field of Pharmaceutical Quality Assurance and Pharmaceutical Analysis on the basis of its originality, importance, disciplinary interest, timeliness, accessibility, elegance, and surprising conclusions. IJPQA also provides rapid, authoritative, insightful and arresting news and interpretation of topical and coming trends affecting science, scientists and the wider public.