{"title":"新的意大利器械注册要求。","authors":"Maria Donawa","doi":"","DOIUrl":null,"url":null,"abstract":"<p><p>A medical device manufacturer located outside Europe was informed by an Italian distributor that the European Authorised Representative must designate the distributor as the authorised entity when registering the manufacturer's devices in Italy in a new online data bank. This is incorrect. This article discusses the new requirements for registering medical devices in Italy, together with the steps in the registration process and common problems encountered.</p>","PeriodicalId":80066,"journal":{"name":"Medical device technology","volume":"19 3","pages":"26, 28-9, 31"},"PeriodicalIF":0.0000,"publicationDate":"2008-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"New Italian device registration requirements.\",\"authors\":\"Maria Donawa\",\"doi\":\"\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>A medical device manufacturer located outside Europe was informed by an Italian distributor that the European Authorised Representative must designate the distributor as the authorised entity when registering the manufacturer's devices in Italy in a new online data bank. This is incorrect. This article discusses the new requirements for registering medical devices in Italy, together with the steps in the registration process and common problems encountered.</p>\",\"PeriodicalId\":80066,\"journal\":{\"name\":\"Medical device technology\",\"volume\":\"19 3\",\"pages\":\"26, 28-9, 31\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2008-05-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Medical device technology\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Medical device technology","FirstCategoryId":"1085","ListUrlMain":"","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
A medical device manufacturer located outside Europe was informed by an Italian distributor that the European Authorised Representative must designate the distributor as the authorised entity when registering the manufacturer's devices in Italy in a new online data bank. This is incorrect. This article discusses the new requirements for registering medical devices in Italy, together with the steps in the registration process and common problems encountered.
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