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Showing 3651–3660 of 65809 articles for “Art. R 212-1/2”
The Agence nationale de sécurité du médicament et des produits de santé may, for the purposes of exporting cosmetic products to States which are neither members of the European Union nor parties to th…
The operator must ensure that the maintenance and quality controls required for the medical devices it operates are carried out. Maintenance is carried out either by the manufacturer or under his resp…
The Agence nationale de sécurité du médicament et des produits de santé submits to its control a sample of each batch of the substance which, if used separately from the medical device in which it is…
In application of Article L. 5212-1, the list of medical devices subject to compulsory maintenance, the list of medical devices subject to internal quality control and the list of medical devices subj…
For the devices mentioned in Article R. 5212-26, with the exception of those used during exposure to ionising radiation, subject to internal or external quality control, the Director General of the Ag…
When informed of one of the events mentioned in Article L. 5212-2, the Director of the Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Med…
Manufacturers of medical devices and the companies and organisations operating these devices shall, at the reasoned request of the Director of the Agence nationale de sécurité du médicament et des pro…
Without prejudice to the obligations to provide information laid down by Article L. 5212-2 or by any other legislative or regulatory provision, the staff of the Agence nationale de sécurité du médicam…
I.-External quality control of medical devices is carried out by bodies accredited for this purpose by the Comité français d'accréditation or by any other accreditation body which is a signatory to a…
The rules of procedure are drawn up and adopted by the Strategic Committee, after consultation with the joint bodies and, in accordance with their respective remits, with the bodies of the institution…
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