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Showing 13371–13380 of 39711 articles for “Art. al. 3”
The authorisation is issued for a period of five years. At the request of the holder, submitted no later than two months before the normal expiry date, the initial authorisation is renewed for a perio…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé will notify the applicant of his prior authorisation decision within two months of the date of receipt o…
…for authorisation to advertise the in vitro diagnostic medical devices referred to in Article L. 5223-3 must be sent to the Director General of the Agence nationale de sécurité du médicament et des pr…
…h, under these regulations, bears the CE mark"; h) Where applicable, the internal reference number; 3° Does not include any statement to the effect that the in vitro diagnostic medical device is reimb…
The authorisation is issued for a period of five years. At the request of the holder, submitted no later than two months before the normal expiry date, the initial authorisation is renewed for a perio…
…nds that advertising for a medical device, which is not covered by the provisions of Articles R. 5213-5 to R. 5213-11, is being disseminated under conditions which contravene the provisions of Article…
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.
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 decisions taken by the approved bodies under the procedures referred to in sub-sections 4, 5 and 6 of section 6 of this chapter are valid for five years. They may be renewed for five-year periods…
…ents and control materials which enable the user to ascertain or verify the performance of devices; 3° Products intended for general laboratory use unless, in view of their characteristics, they are s…
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