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Global Medical Device Nomenclature (GMDN) is a system of internationally agreed generic descriptors used to identify all medical device products. This nomenclature is a naming system for products which include those used for the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans.
This article needs to be updated.The reason given is: the section related to E.U. needs further updates (esp. in sections 3.2 and 4.2.2) as the directives 93/42/EEC on medical devices and 90/385/EEC on active implantable medical devices have been fully repealed on 26 May 2021 by Regulation (EU) no. 2017/745 (MDR); furthermore, Brexit triggers updates in these sections (U.K. developed their own ...
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 ...
Unlike the names in the list above, these names are still widely known by the public as brand names, and are not used by competitors. Scholars disagree as to whether the use of a recognized trademark name for similar products can truly be called "generic", or if it is instead a form of synecdoche .
The process involved in product naming can take months or years to complete. Some key steps include specifying the objectives of the branding, developing the product name itself, evaluating names through target market testing and focus groups, choosing a final product name, and finally identifying it as a trademark for protection. [1]
A formulary is a list of pharmaceutical drugs, often decided upon by a group of people, for various reasons such as insurance coverage or use at a medical facility. [1] Traditionally, a formulary contained a collection of formulas for the compounding and testing of medication (a resource closer to what would be referred to as a pharmacopoeia ...
The Unique Device Identification (UDI) System is intended to assign a unique identifier to medical devices within the United States, Europe, China, South Korea, Saudi Arabia and Taiwan. [1] It was signed into law in the US on September 27, 2007, as part of the Food and Drug Administration Amendments Act (Section 226) of 2007 .
In 2017, Codman Neurosurgery, part of Depuy Synthes, was acquired by medical device maker Integra LifeSciences for $1.045 billion. [9] On September 14, 2023, Johnson & Johnson announced its MedTech and pharmaceutical segments were uniting under the Johnson & Johnson brand name. [10]