possiblefindingthatapplicablestatutoryorregulatoryrequirementshavenotbeenmet. Asacorollarytotheabove,itisequallyimportanttonotethatHealthCanadareservestheright torequestinformationormaterial,ordefineconditionsnotspecificallydescribedinthis guidance,inordertoallowtheDepartmenttoadequatelyassessthesafety,efficacyorqualityof ...
Canadian authorities are seeking public input through 27 March on a proposal to make a number of changes to the drug and medical device regulations in an effort to modernise and streamline current requirements. Health Canada notes that the proposed targeted provisions and regulatory amendments to th...
JL Webster - 《Medical Device Technology》 被引量: 2发表: 1998年 The reuse of medical devices Examines legal aspects of reusing medical devices outside the manufacturer's labelled indications of use. Regulation of medical devices; Labelling requirements relating to single use and reuse; Manufacturer...
This communication is critical for you if you migrated your CE certificates from BSI UK (0086) to BSI NL (2797), and you are currently completing your labelling transitions, and there is any possibility of a delay to your strategy, which means that you may not complete all labelling transiti...
英文名称:Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements 标准状态:废止 发布日期:2012-06-25 文档简介 1.标签和标签要求:医疗器械应配有清晰的标签,包括产品的名称、制造商的名称和地址、产品的描述、必要的警示信...
MDR 2017/745 Annex 1 23.2(q)The requirements for indicating that a device is a medical device; Medical Device Regulation.Medical deviceIndicates that the device is a medical device. N/AN/ATelephone receiver or handsetIndicates the telephone contact number. ...
device into compliance with the requirements of this Regulation relating to the risk presented by the device and, in a manner that is proportionate to the nature of the risk, to restrict the making available of the device on the market, to subject the making available of the device to ...
Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates当指令93/42/EEC第7.5节第2段附录I要求时,BS EN 15986:2011规定了医疗器械或医疗器械零件的标签要求,以表明存在邻苯二甲酸酯.这具体包括标签中使用的符号格式.BS EN 15986:2011未规定医疗...
and additional existing methods are available to provide such assurances. Therefore, Class II devices are also subject to special controls; special controls may include special labelling requirements, mandatory performance standards, and postmarket surveillance.3Devices in this class are typically non-invasi...
【英语版】国际标准 ISO 15223-1:2012 EN Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements 医疗器械 医疗器械标签、标贴和所提供信息使用的符号 第1部分:一般要求.pdf,ISO