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Showing 4181–4190 of 60140 articles for “Art. 16e ch. A”
If a system or kit does not meet the conditions set out in Article R. 5211-67, and in particular if it contains devices not bearing the CE marking or if the compatibility of the assembled devices is n…
The systems and kits are accompanied by the information mentioned in Article R. 5211-22, including, where applicable, the information supplied by the manufacturers of the devices that have been assemb…
A natural or legal person who assembles devices bearing the CE marking, in accordance with their intended purpose and within the limits of use laid down by their manufacturers, in order to place them…
As part of the procedure applicable to in vitro diagnostic medical devices undergoing an assessment of their performance, the manufacturer must draw up a declaration containing the data enabling the d…
When the Groupement de Coopération Sanitaire applies for authorisation for healthcare activities, the conditions for establishment set out in article L. 6123-1 and the technical operating conditions s…
I - When the Director General of the Regional Health Agency grants a healthcare activity authorisation to a private health cooperation grouping, the private health establishment resulting from the gro…
I.-In application of the third paragraph of article L. 6133-8, the Director General of the Regional Health Agency decides on the applicable fee scale, after taking note of the option expressed by the…
When the Director General of the Regional Health Agency withdraws, or does not renew, a healthcare activity authorisation granted to a Groupement de Coopération Sanitaire set up as a private health es…
I.-When the Director General of the Regional Health Agency grants authorisation for healthcare activities for the first time to a healthcare cooperation grouping whose constituent agreement he has pre…
The application for authorisation referred to in Article R. 6213-5 must be sent to the national management centre by registered letter with acknowledgement of receipt, accompanied by a dossier, the co…
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