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Showing 5811–5820 of 32230 articles for “Art. Loi 2011-900 du 29-7-2011”
The bodies responsible for implementing the assessment procedures provided for in this Title shall be authorised for this purpose by a decision of the Director General of the Agence nationale de sécur…
As part of the EC verification procedure, the manufacturer shall submit to an authorized body for inspection devices manufactured in conformity with an approved type as described in an EC type-examina…
The provisions of Section 7 of Chapter I of Title I of this Book, with the exception of Article R. 5211-54, the second paragraph of Article R. 5211-55 and Articles R. 5211-55-1, R. 5211-62 and R. 5211…
Authorised bodies shall inform the Director General of the Agence nationale de sécurité du médicament et des produits de santé : 1° of any modification likely to alter the conditions under which autho…
…1° All suspended or cancelled certificates ; 2° On request, of all decisions taken under the procedures defined in this section and of all certificates issued or refused. They shall also make availa…
The decisions taken by the approved bodies under the procedures referred to in sub-sections 4, 5 and 6 of section 6 of this chapter are valid for five years. They may be renewed for five-year periods…
…several units, if the size of the establishment justifies it, organised to care for patients who, due to the seriousness of their condition or the treatment they are receiving, require repeated and…
…arenal purification. This healthcare establishment installs a haemodialysis machine and a system producing water for haemodialysis in the home of the patient it cares for. It also provides the medicin…
The continuous surveillance unit may operate in a health care establishment that has neither a resuscitation unit nor an intensive care unit if it has signed an agreement specifying the conditions for…
The managing health care establishment provides appropriate training for the patient and the third party who will assist him, either in a haemodialysis centre, in a medical dialysis unit or in an inde…
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