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Showing 5541–5550 of 12140 articles for “Art. 7°”
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…
I.-The approved bodies must comply with the following obligations: 1° The approved body, its director and the personnel responsible for carrying out the assessment and verification operations may not…
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…
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…
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fulfil the conditions or fails to meet the obligations mentioned in Article R. 5211-56, accreditation is suspended or withdrawn by the Director General of the Agence na…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…
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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