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Showing 13381–13390 of 39711 articles for “Art. al. 3”
The application for authorisation to advertise the medical devices referred to in Article L. 5213-4 shall be sent to the Director General of the Agence nationale de sécurité du médicament et des produ…
By way of derogation from the provisions of article R. 5212-35-4, where the second-hand medical device being transferred has never been put into service, the file is composed solely of the following e…
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…
…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…
…medical device no longer complies with the conditions laid down by the provisions of Articles L. 5213-2 and L. 5213-4, and by the provisions of this chapter. Suspension or withdrawal may only take pla…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé will notify the applicant of his decision on prior authorisation within two months of the date of receip…
The Director General of the Agence Nationale de Sécurité du Médicament et des Produits de Santé may require the communication of all information essential for checking the accuracy of the advertised c…
…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,…
…t relating to the maintenance of the performance of the medical device mentioned in article R. 5212-30 must be less than six months old; 2° A description of all modifications made to the device since…
The certificate drawn up by the person responsible for the transfer of the second-hand medical device certifies that it has undergone regular maintenance in accordance with the provisions of article R…
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