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Showing 11341–11350 of 38939 articles for “Art. al. 4”
The certificate is accompanied by a file containing the following information: 1° The information contained in the register mentioned in 5° of article R. 5212-28 since the acquisition of the medical d…
For the application of the provisions of this chapter, army hospitals are considered to be public health establishments.
…tic medical device intended by the manufacturer to be used by the public in a domestic environment; 4° Device undergoing a performance evaluation: any in vitro diagnostic medical device subjected by t…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé shall carry out his duties relating to reactovigilance under the conditions defined in Article R. 5311-2…
As part of the procedure for the EC declaration of conformity, product quality assurance, for class II b medical devices, the manufacturer must submit an application to the authorized body for assessm…
…devices and send it the batch release certificate for the substance referred to in Article R. 5212-24 used in this device, drawn up by the Agence nationale de sécurité du médicament et des produits de…
The conditions for implementing the essential requirements defined in this section are specified, on a proposal from the Director General of the Agence nationale de sécurité du médicament et des produ…
The agents authorised by the Director General of the agency to perform the duties of inspector shall take the following oath before the judicial court within whose jurisdiction the head office of the…
The Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail sends a warning to the company in question, together with the inspection report o…
For Class IIa medical devices or Class I medical devices, the provisions of Article R. 5211-43 apply subject to the following modifications: 1° For class II a medical devices, the authorised body veri…
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