Article R5221-30
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…
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Showing 8351–8360 of 47428 articles for “Art. 3 mai 2007”
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…
The approved body shall inform the other approved bodies in France or in the other Member States of the European Union or parties to the Agreement on the European Economic Area and which have been pub…
Each user department of a medical device on the list provided for in Article R. 5212-36 completes the information mentioned in Article R. 5212-38 by recording:-the date of use ;the identification of t…
…the data relating to the dispensing of medical devices on the list provided for in Article R. 5212-36. This record includes the following information:-the identification of each medical device: name,…
…orted in accordance with the same article, accompanied by the report referred to in article R. 5212-30, if the device has undergone external quality control. A copy of the report is sent to the Direct…
Manufacturers who place in vitro diagnostic medical devices on the French market and who do not have their registered office on the territory of a Member State of the European Union or a party to the…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé is notified of any changes to the information contained in the declaration.
…quested for authorisation or in the declaration or descriptive dossier provided for in Article L. 5138-1, in accordance with the conditions laid down in Articles R. 5138-1 and R. 5138-2, shall be puni…
A manufacturer, importer or distributor who has registered a reagent is liable to a fine of the fifth class for failing to forward to the Agence nationale de sécurité du médicament et des produits de…
…e R. 5441-1 are liable, in addition to a fine in accordance with the procedures set out in article 131-41 of the French Penal Code, to the confiscation of the veterinary medicinal product which was us…
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