Book II: Medical devices, in vitro diagnostic medical devices and other products and articles regulated in the interests of public health

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 characteristics and performances.

The Director General of the Agence nationale de sécurité du médicament et des produits de santé will notify the applicant of his decision on prior authorisation within two months of the date of receipt of the complete dossier. Authorisation is deemed to have been granted in the absence of a decision by the Director General of the Agency within this period. If the applicant’s documents are not complete, the Agence…

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 period of five years.

Any project to modify the elements mentioned in 1° and 2° of article R. 5213-5 is the subject of a new authorisation application submitted and examined under the same conditions as the initial authorisation application. This authorisation continues to run until its initial expiry date.

Authorisation may be suspended or withdrawn by reasoned decision of the Director General of the Agence nationale de sécurité du médicament et des produits de santé where the advertising of the medical device no longer complies with the conditions laid down by the provisions of Articles L. 5213-2 and L. 5213-4, and by the provisions of this chapter. Suspension or withdrawal may only take place after the holder has been…

In an emergency, the Director General of the Agence nationale de sécurité du médicament et des produits de santé may suspend the authorisation of an advertisement for a maximum period of three months.