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Showing 1931–1940 of 16740 articles for “Art. Aut. conc. n° 12-D-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…
The suspension, which may not exceed one year, and the withdrawal of the authorisation to open, provided for in article L. 5142-2, are decided by the Director General of the Agence nationale de sécuri…
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.
The following 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…
The Chief Executive is the authorising officer for the revenue and expenditure of the Agency's budget. He may appoint secondary authorising officers. He may delegate his signature to staff under his a…
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…
As part of emergency medical assistance, the mobile emergency and resuscitation structure mentioned in article R. 6123-1 has the following mission: 1° To ensure, on a permanent basis, in all places an…
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