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Showing 5061–5070 of 33647 articles for “Art. 1231 to 1231-7”
…gency for the Safety of Medicines and Health Products) shall carry out surveillance and ongoing monitoring of the bodies it has authorised to ensure ongoing compliance with the obligations listed in A…
…the medical devices with an approved type described in an EC type-examination certificate referred to in Article R. 5211-41 or with the technical documentation referred to in Article R. 5211-39 under…
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fulfil the conditions or fails to meet the obligations mentioned in Article R. 5211-56, accreditation is suspended or withdrawn by the Director General of the Agence na…
…ss, legal status ; - a precise description of the scope of the assessment requested and a reference to the directives and national provisions transposing them.
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…
…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 verifies the…
…unters difficulties in implementing the conformity assessment procedures, it shall refer the matter to the Director General of the Agence nationale de sécurité du médicament et des produits de santé f…
…rocedures provided for in this Title shall be authorised for this purpose by a decision of the Director General of the Agence nationale de sécurité du médicament et des produits de santé published on…
As part of the EC verification procedure, the manufacturer shall submit to an authorized body for inspection devices manufactured in conformity with an approved type as described in an EC type-examina…
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