Article R5221-13
The presentation at scientific or technical meetings, exhibitions and demonstrations of in vitro diagnostic medical devices which do not comply with the provisions of this Title is authorised provided…
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Showing 9591–9600 of 60179 articles for “Art. R 145-29-1”
The presentation at scientific or technical meetings, exhibitions and demonstrations of in vitro diagnostic medical devices which do not comply with the provisions of this Title is authorised provided…
For the purposes of this chapter, army hospitals and the army blood transfusion centre are considered, respectively, as public health establishments and as a blood transfusion establishment. The local…
All manufacturers of in vitro diagnostic medical devices, or their representatives, shall appoint a person to be responsible for reactovigilance, whose identity and position shall be communicated to t…
Every manufacturer of medical devices, or its authorised representative, appoints a material vigilance correspondent and communicates his name to the Director General of the Agence nationale de sécuri…
In an emergency, the Director General of the Agence nationale de sécurité du médicament et des produits de santé may suspend the authorisation of an advertisement for a maximum period of three months.
The CE marking may be affixed to an in vitro diagnostic medical device only if it complies with the essential requirements and has undergone the assessment procedures applicable to it. Where an in vit…
All in vitro diagnostic medical devices imported, placed on the market or put into service must bear the CE mark. However, CE marking is not required for devices undergoing a performance evaluation or…
At the request of the Director General of the Agence nationale de sécurité du médicament et des produits de santé, the manufacturer or its authorised representative shall provide any information relat…
Authorisation may be suspended or withdrawn by reasoned decision of the Director General of the Agence nationale de sécurité du médicament et des produits de santé where the advertising of the medical…
Manufacturers or their agents, importers and distributors shall declare without delay to the Director General of the Agence nationale de sécurité du médicament et des produits de santé any incidents o…
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