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Showing 9121–9130 of 51783 articles for “Art. L 224-3”
The exercise of material vigilance may involve, in addition to the communication by the manufacturer of the documents mentioned in Article R. 5211-26, access to data in the pre-clinical experimental f…
For medical devices, the list of which is set by order of the Minister for Health on a proposal from the Director General of the Agence nationale de sécurité du médicament et des produits de santé (Fr…
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 pharmacist in charge of managing the in-house pharmacy or, for establishments without an in-house pharmacy, the person in charge of ordering and managing stocks in the establishment, under the sup…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé may give formal notice to any operator of a medical device subject to the quality control provided for i…
…dies 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 on application submitted at a time con…
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.
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