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Showing 5801–5810 of 32230 articles for “Art. Loi 2011-900 du 29-7-2011”
…the quality system. The manufacturer undertakes to implement and keep up to date a systematic procedure for examining the data acquired on medical devices and, where appropriate, on aspects relating…
…The approved body must make available to the Director General of the Agence nationale de sécurité du médicament et des produits de santé the relevant documents relating to the assessment of the subc…
The Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products) shall carry out surveillance and ongoing monitoring of…
As part of the EC verification procedure, the manufacturer submits the devices manufactured for inspection by an authorised body. The authorised body checks the conformity of the medical devices with…
The decisions taken by the approved bodies under the procedures referred to in subsections 5, 6, 8 and 9 of section 6 of this chapter are valid for five years. They may be renewed for five-year period…
…accreditation is suspended or withdrawn by the Director General of the Agence nationale de sécurité du médicament et des produits de santé, after the head of the body has been asked to present his obs…
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…
…s with the technical documentation drawn up in application of the EC declaration of conformity procedure, and not with an EC type certificate, and with the essential requirements applicable to them. I…
Where the authorised body encounters difficulties in implementing the conformity assessment procedures, it shall refer the matter to the Director General of the Agence nationale de sécurité du médicam…
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