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Showing 4681–4690 of 17962 articles for “Art. 5 avr. 2011”
…des produits de santé, specifies the conditions for applying the procedures defined in Articles R. 5211-37 to R. 5211-52.
For the purposes of this Title, the following definitions shall apply1° Operator of a medical device: any natural or legal person who assumes legal responsibility for the activity requiring the use of…
As part of the procedure applicable to custom-made medical devices, the manufacturer must draw up documentation including the name and address of the manufacturer, the place or places of manufacture,…
…dited body ceases to fulfil the conditions or fails to meet the obligations mentioned in Article R. 5211-56, accreditation is suspended or withdrawn by the Director General of the Agence nationale de…
Before examining the application for assessment, the approved body will ensure that the file includes in particular : - the general characteristics of the applicant, such as company name, name, addres…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé shall decide on the application within seven months of the date of receipt of the complete file. Failing…
…ly of veterinary medicinal products by the groups provided for in the first paragraph of article L. 5143-6 are carried out under the supervision of a pharmacist who actually participates in the techni…
In each region, regional material vigilance and reactovigilance coordinators carry out their vigilance duties under the conditions defined in article R. 1413-61-4.
…s) carries out his duties relating to material vigilance under the conditions defined in Article R. 5311-2 and ensures compliance with the monitoring procedures organised by this chapter.It informs th…
The application for authorisation to advertise the medical devices referred to in Article L. 5213-4 shall be sent to the Director General of the Agence nationale de sécurité du médicament et des produ…
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