Article R5141-144
…the research and scientific evaluation activities referred to in the third paragraph of Article L. 5141-13-1 : a) The unsigned agreement, indicating the name, company name and registered office addres…
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Showing 1541–1550 of 4654 articles for “Art. 14 févr. 2012”
…the research and scientific evaluation activities referred to in the third paragraph of Article L. 5141-13-1 : a) The unsigned agreement, indicating the name, company name and registered office addres…
The CE marking may be affixed to a medical device only if it complies with the essential health and safety requirements referred to in Section 5 of this Chapter and has undergone the certification pro…
Incidents or risks of incidents as defined in Article L. 5212-2 must be reported immediately.
Manufacturers or their agents, importers and distributors shall declare without delay to the Director General of the Agence nationale de sécurité du médicament et des produits de santé any incidents o…
The provisions of articles R. 5211-15, R. 5211-17, R. 5211-19 and R. 5211-20 are applicable to in vitro diagnostic medical devices.
The Director General of the Agence nationale de sécurité du médicament et des produits de santé is appointed for a period of three years, renewable once. He manages the establishment. He performs all…
In order to provide the most appropriate equipment for the needs of the person who is ill or has an incapacity or disability, the service provider and the equipment distributor will ask the prescriber…
…f information concerning nosocomial infections which must be reported in accordance with article R. 1413-79 is organised according to procedures defined by the institutional medical committee or the i…
…ult medical records or documents under the conditions laid down in the last paragraph of article L. 1414-4. If these conditions are not met, the files or documents in question shall be rendered anonym…
The location of the SMURs mentioned in 2° of article R. 6123-1 is determined by the regional health plan and ensures territorial coverage.
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