Article R5142-9
…ph of article L. 5142-2 is required for the following substantial changes:-carrying out a new pharmaceutical activity within the meaning of article R. 5142-1;-the manufacture or import of a new catego…
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Showing 3441–3450 of 10201 articles for “Art. CE 29-9-1989 n° 68212”
…ph of article L. 5142-2 is required for the following substantial changes:-carrying out a new pharmaceutical activity within the meaning of article R. 5142-1;-the manufacture or import of a new catego…
For the purposes of this Title, accessories to medical devices are treated as devices in their own right. Accessories are classified as such, independently of the devices with which they are used, wit…
…lted with a view to setting up the Commission, have not formulated a proposal within one month of receiving the request from the Regional Prefect, the latter may proceed to appoint the members of the…
…ial penalties and daily fines provided for in Article L. 5145-5 are recovered by the accounting officer of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travai…
In vitro diagnostic medical devices appearing on the list established by the order referred to in Article R. 5221-6, designed and manufactured in accordance with common technical specifications publis…
Any project to modify the elements mentioned in 1° and 2° of article R. 5213-5 is the subject of a new authorisation application submitted and examined under the same conditions as the initial authori…
…its members request to be included on the agenda for the next meeting are automatically included. Except in cases of urgency, when they are to be discussed, these questions must be tabled at least fif…
Service providers and equipment distributors update their professional knowledge and keep abreast of developments in best practice, legislation and regulations.
Any project to modify the elements mentioned in 1° and 2° of article R. 5223-5 is the subject of a new application for authorisation submitted and examined under the same conditions as the initial app…
…s of the health care organisation define, after consultation with the medical commission or conference, the procedures for implementing the collection, processing, validation and internal transmission…
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