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Showing 3991–4000 of 33647 articles for “Art. 1231 to 1231-7”
…purposes of this Title, medical devices other than active implantable medical devices are divided into four classes known as Class I, Class IIa, Class IIb and Class III. Whether a device belongs to on…
…thorised body involved in the conformity assessment procedures provided for in this Title, the Director General of the Agence nationale de sécurité du médicament et des produits de santé shall determi…
The regional material vigilance and reactovigilance coordinators carry out their vigilance duties under the conditions defined in article R. 1413-61-4.
Prescriptions for medical devices issued at the request of a patient with a view to obtaining a supply in another Member State of the European Union must include the following information: 1° The surn…
When the prescription includes the information provided for in 1°, subject to adaptation of the country information, to 3° of Article R. 5211-70, persons legally authorised to supply medical devices m…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé will notify the applicant of his decision on prior authorisation within two months of the date of receip…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé will notify the applicant of his prior authorisation decision within two months of the date of receipt o…
…rying out checks on the application of the provisions of Title II of Book I of Part I and the regulatory measures taken for its application falling within the remit of the Agence nationale de sécurité…
The duties of members of the Board of Directors are performed free of charge. Travel and accommodation expenses are reimbursed in accordance with the regulations applicable to civil servants.
…ws: 1° Under 1° of I : For the analysis of samples and the assessment of the documentation relating to the control protocol submitted by the manufacturer, with a view to the release of batches of immu…
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