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Showing 5001–5010 of 34464 articles for “Art. 7 mai 2002”
Authorised bodies shall inform the Director General of the Agence nationale de sécurité du médicament et des produits de santé of any change likely to alter the conditions under which authorisation ha…
…ile condition, the manufacturer must also undertake to keep the quality system set up to obtain and maintain this condition suitable and effective and to fulfil the obligations arising from the qualit…
…or as agents of the parties involved in these activities, in the design, construction, marketing or maintenance of these devices. This does not exclude the possibility of an exchange of technical info…
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…
…he has set up to ensure that his devices are manufactured in a sterile state and that this state is maintained.
…body shall examine at least the aspects provided for in point 2.2 of Annex I to Regulation (EU) No 722/2012 of 8 August 2012 on specific requirements as regards the requirements laid down in Council…
If an accredited 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fulfil the conditions or fails to meet the obligations mentioned in Article R. 5211-56, accreditation is suspended or withdrawn by the Director General of the Agence na…
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…
…f the Director General of the Agence nationale de sécurité du médicament et des produits de santé remains silent, he will be deemed to have refused authorisation on expiry of this seven-month period.…
For Class IIa medical devices or Class I medical devices, the provisions of Article R. 5211-43 apply subject to the following modifications: 1° For class II a medical devices, the authorised body veri…
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