Article R5213-3
The information contained in each advertisement must be accurate, up-to-date, verifiable and sufficiently complete to enable, as appropriate, the general public to understand the intended use of the m…
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Showing 13411–13420 of 39711 articles for “Art. al. 3”
The information contained in each advertisement must be accurate, up-to-date, verifiable and sufficiently complete to enable, as appropriate, the general public to understand the intended use of the m…
…cond quality control carried out on the device in accordance with the provisions of Article R. 5212-30.If, after this second inspection, the expected performance of the device is still not achieved, t…
The content and methods of presentation of the declaration are laid down, on a proposal from the Director General of the Agence nationale de sécurité du médicament et des produits de santé, by order o…
The bodies responsible for implementing the assessment procedures provided for in this Title shall be authorised for this purpose by a decision of the Director General of the Agence nationale de sécur…
The presentation at scientific or technical meetings, exhibitions and demonstrations of in vitro diagnostic medical devices which do not comply with the provisions of this Title is authorised provided…
…e quality control has led to the reporting of a risk of incident as provided for in Article R. 5212-31, the operator shall notify the Director General of the Agence nationale de sécurité du médicament…
…August 2012 on specific requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC for active implantable medical devices and medical devices manufactured utilis…
…cting pharmacists and veterinarians mentioned in article R. 206-1 and in 2° of the I of article R. 231-3-7 of the rural and maritime fishing code working as inspectors for the agency when they have al…
…ation of conformity, associated with the EC declaration of conformity, product quality assurance, ; 3° For Class II b medical devices, either : a) the EC declaration of conformity, full quality assura…
…Products which, because of their principal mode of action, are considered to be medicinal products; 3° Cosmetic products;4° Human blood, blood products, blood cells of human origin or devices containi…
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