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Jurisdiction Definition Legislation Australia A medical device that: (a) is made specifically in accordance with a request by a health professional specifying the design characteristics or construction of the medical device; and (b) is intended: (i) to be used only in relation to a particular individual; or (ii) to be used by the health professional to meet special needs arising in the course ...
English: These Regulations contain the legislative measures necessary for the implementation of three European Community Directives- Council Directive 90-385-EEC on the approximation of the laws of the Member States relating to active implantable medical devices, as amended; Council Directive 93-42-EEC concerning medical devices, as amended; and Directive 98-79-EC of the European Parliament ...
Medical Devices regulations cover all the topics related to the laws, standards or submissions process, with which compliance is required by manifold national and international bodies to commercialize a medical device
The Medical Device Directive—Council Directive 93/42/EEC of 14 June 1993 concerning medical devices—is intended to harmonise the laws relating to medical devices within the European Union. The MD Directive is a 'New Approach' Directive and consequently in order for a manufacturer to legally place a medical device on the European market the ...
The Therapeutic Goods (Medical Devices) 2007 Regulations require a healthcare facility that reprocesses single-use devices to be licensed as a manufacturer. A healthcare facility that reprocesses single use devices would be considered to be a manufacturer under the Act and thus would be required to conform to the regulation and be subject to ...
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Medical device regulation may refer to: Regulation (EU) 2017/745 in the European Union; Medical Device Regulation Act of 1976 in the United States
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