Article R5141-15
The application for marketing authorisation is accompanied by a draft summary of product characteristics, the presentation and content of which are laid down in accordance with Article 14 of Directive…
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Showing 1961–1970 of 32005 articles for “Art. Cass. com. 15 October 1996 n° 94-18.903 · CA Paris 7 November 2014 n° 12/17749”
The application for marketing authorisation is accompanied by a draft summary of product characteristics, the presentation and content of which are laid down in accordance with Article 14 of Directive…
The affixing of marks or inscriptions on a medical device, on its packaging or on the instructions for use which are likely to mislead as to the meaning or form of the CE marking is prohibited. Any ot…
The provisions of article R. 5211-21 are applicable to in vitro diagnostic medical devices.
…g incidents may be reported: 1° A noxious and unintended reaction occurring during the use of a medical device in accordance with its intended purpose; 2° A noxious and unintended reaction resulting f…
…uthority. These delegations are published on the website of the Agence nationale de sécurité du médicament et des produits de santé.
The certification procedure established by the Haute Autorité de santé provides in particular for :1° Informing the institution, all the institutions involved or associated with the regional hospital…
In healthcare establishments, the head of the establishment appoints, after consulting the establishment's medical committee or medical conference, the healthcare professional responsible for notifyin…
The National Committee meets as a section or in plenary session, when convened by the minister(s) responsible for social action, health and social security. The secretariat is provided by the departme…
…least once a year, the regional health agency consults the regional federation of independent healthcare professionals on the guidelines and evaluation of the multi-year contracts for objectives and r…
The authorisation holder participates, where necessary, in the permanent care service referred to in Article L. 6111-1-3.
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