Article R5211-65
…e of the European Union or party to the Agreement on the European Economic Area, places class I medical devices or custom-made medical devices on the market in its own name, shall make a declaration t…
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Showing 4931–4940 of 16327 articles for “Art. CA Paris 28-6-1994”
…e of the European Union or party to the Agreement on the European Economic Area, places class I medical devices or custom-made medical devices on the market in its own name, shall make a declaration t…
…the company in question, together with the inspection report or the results of the checks or verifications, indicating the facts that are attributed to it and that may justify the initiation of a san…
…dures, it shall refer the matter to the Director General of the Agence nationale de sécurité du médicament et des produits de santé for specific recommendations on their application.
The Director General of the Agence nationale de sécurité du médicament et des produits de santé shall inform without delay of any incident or risk of incident defined in Article L. 5212-2:the Etabliss…
In vitro diagnostic medical devices, other than in vitro diagnostic medical devices undergoing performance evaluation, are classified in two categories: 1° In vitro diagnostic medical devices whose re…
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…
…roviders and equipment distributors shall respect the right of persons who are ill or who have an incapacity or disability to consult the healthcare professional of their choice. They are prohibited f…
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 inspectors of the Agence nationale de sécurité du médicament et des produits de santé are authorised by the Minister for Defence to work in the pharmaceutical establishments of the central pharmac…
…and the Chairman of the Scientific Council attend meetings of the Board of Directors in an advisory capacity. The Chief Executive Officer may also be assisted by any person of his choice. The Chairman…
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