{"title":"医疗器械监管框架的变化:回顾与展望","authors":"Pietro Gervasoni","doi":"10.54920/scto.2023.rawatch.8.2","DOIUrl":null,"url":null,"abstract":"The new regulatory framework for medical devices was long due. It aims to improve the safety and performance of medical devices and ensure a high level of protection for public health. Yet complying with the new legislation requires greater administrative effort and more resources, thus making compliance more expensive. In addition, there has been some uncertainty among researchers about how to correctly comply with the new legislation. This article looks back at the measures swissethics has taken to address some of these challenges and looks forward to additional measures to be implemented in the future.","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"46 1","pages":"0"},"PeriodicalIF":0.0000,"publicationDate":"2023-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Changes to the medical device regulatory framework: Looking back – and forward\",\"authors\":\"Pietro Gervasoni\",\"doi\":\"10.54920/scto.2023.rawatch.8.2\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"The new regulatory framework for medical devices was long due. It aims to improve the safety and performance of medical devices and ensure a high level of protection for public health. Yet complying with the new legislation requires greater administrative effort and more resources, thus making compliance more expensive. In addition, there has been some uncertainty among researchers about how to correctly comply with the new legislation. This article looks back at the measures swissethics has taken to address some of these challenges and looks forward to additional measures to be implemented in the future.\",\"PeriodicalId\":419230,\"journal\":{\"name\":\"Regulatory Affairs Watch\",\"volume\":\"46 1\",\"pages\":\"0\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2023-06-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Regulatory Affairs Watch\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.54920/scto.2023.rawatch.8.2\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Regulatory Affairs Watch","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.54920/scto.2023.rawatch.8.2","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Changes to the medical device regulatory framework: Looking back – and forward
The new regulatory framework for medical devices was long due. It aims to improve the safety and performance of medical devices and ensure a high level of protection for public health. Yet complying with the new legislation requires greater administrative effort and more resources, thus making compliance more expensive. In addition, there has been some uncertainty among researchers about how to correctly comply with the new legislation. This article looks back at the measures swissethics has taken to address some of these challenges and looks forward to additional measures to be implemented in the future.
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