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Showing 5011–5020 of 34610 articles for “Art. 7 mai 2020”
The General Director of the Agence nationale de sécurité du médicament et des produits de santé regularly checks that the authorised body has the required skills and up-to-date knowledge of the medica…
Authorised bodies shall inform the Director General of the Agence nationale de sécurité du médicament et des produits de santé of all certificates issued, modified, supplemented, suspended, withdrawn…
The approved body may require the manufacturer to provide any information and to carry out any test or assessment necessary for it to carry out the verifications for which it is responsible.
Where an authorized body finds that the requirements of this Title applicable to this device have not been met or are no longer being met by the manufacturer, or where a certificate should not have be…
The bodies responsible for carrying out 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…
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.
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