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Showing 1721–1730 of 4065 articles for “Art. BOI-RPPM-PVBMI-70-20 — resale outcome”
Reports are made :1° To the local materiovigilance correspondent when these reports are made by users or third parties who carry out their duties in one of the establishments or associations mentioned…
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…
For the medical devices mentioned in Article R. 5212-26 and used during exposure to ionising radiation :1° Manufacturers shall provide operators with the internal quality control procedures for their…
The reports, whether mandatory or optional, provided for in articles R. 5212-14 and R. 5212-15 are made by manufacturers or their representatives, users or third parties who observe or are aware of in…
When the facts mentioned in Article L. 5212-2 are brought to the attention of the Director General of the Agence nationale de sécurité du médicament et des produits de santé by a user or a third party…
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…
Incidents or risks of incidents as defined in Article L. 5212-2 must be reported immediately.
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…
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