Article R5211-65
Any manufacturer having its registered office in France and who, in any Member State of the European Union or party to the Agreement on the European Economic Area, places class I medical devices or cu…
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Showing 3711–3720 of 9215 articles for “Art. 8 janv. 1997”
Any manufacturer having its registered office in France and who, in any Member State of the European Union or party to the Agreement on the European Economic Area, places class I medical devices or cu…
The declarations provided for in Articles L. 5211-3-1 and R. 5211-65 as well as the communication provided for in Article R. 5211-66 are made to the Agence nationale de sécurité du médicament et des p…
The content and methods of presentation of the declaration are laid down, on a proposal from the Director General of the Agence nationale de sécurité du médicament et des produits de santé, by order o…
The declaration provided for in article L. 5221-3 is made by the manufacturer or his authorised representative, the importer, distributor or exporter of in vitro diagnostic medical devices. The same n…
Manufacturers who place in vitro diagnostic medical devices on the French market and who do not have their registered office on the territory of a Member State of the European Union or a party to the…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé is notified of any changes to the information contained in the declaration.
The neurosurgical care activity mentioned in 12° of article R. 6122-25 includes the care of patients with a pathology affecting the brain, the spinal cord, the peripheral nerves, their envelopes (skul…
…older of the authorisation to practise neurosurgical care must hold the authorisation mentioned in 18° of article R. 6122-25.
The authorisation provided for in article L. 6122-1 may only be issued to a health establishment or a health cooperation grouping if it has the following facilities on the same site, possibly by agree…
Authorisation to carry out neurosurgical care is not required from a health establishment or a health cooperation group when it holds an authorisation to carry out the surgical care activity mentioned…
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