Article R5211-13
…thorised provided that a visible sign clearly indicates that these devices may not be placed on the market or put into service until they have been brought into conformity.
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Showing 1771–1780 of 6154 articles for “Art. 13 Mar 2020”
…thorised provided that a visible sign clearly indicates that these devices may not be placed on the market or put into service until they have been brought into conformity.
…participants and that a visible sign clearly indicates that these devices may not be placed on the market or put into service until they have been brought into compliance.
Every manufacturer of medical devices, or its authorised representative, appoints a material vigilance correspondent and communicates his name to the Director General of the Agence nationale de sécuri…
User healthcare professionals working in one of the establishments mentioned in 4° of Article R. 5222-3 or in a blood transfusion establishment immediately report to the local reactovigilance correspo…
The decisions of the Board of Directors concerning the budget and the financial account are enforceable under the conditions laid down in Title III of Decree no. 2012-1246 of 7 November 2012 on public…
In order to carry out their activities, service providers and equipment distributors have premises reserved for this purpose, including at least one area meeting accessibility requirements for disable…
The contract is for a maximum of five years; it may be revised by amendment.
The granting of a nuclear medicine activity authorisation is subject to compliance with the applicable provisions of Chapter III of Title III of Book III of Part One of this Code.
…erformed by administering a radiopharmaceutical ready for use or prepared in accordance with the summary of product characteristics, using an aseptic process in a closed system; 2° "B" entry, when the…
I.-An "A" nuclear medicine authorisation may only be granted if the holder has a formalised emergency procedure enabling patients to be cared for if necessary, within a timeframe compatible with healt…
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