Article R5133-4
Manufacturers, importers and distributors of reagents, as well as users, and in particular medical biology analysis laboratories, shall transmit to the Agence nationale de sécurité du médicament et de…
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Showing 7061–7070 of 60739 articles for “Art. Cass. 3e Civ. 4-1-1995 n° 88”
Manufacturers, importers and distributors of reagents, as well as users, and in particular medical biology analysis laboratories, shall transmit to the Agence nationale de sécurité du médicament et de…
Decisions to grant, automatically vary, refuse, renew or revoke marketing authorisations subject to the national procedure are taken in accordance with the procedures laid down in Article R. 5141-27 r…
Independently of decisions to suspend, modify or withdraw authorisations and as a precautionary measure, the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'envi…
As part of the EC declaration of conformity procedure, production quality assurance, the manufacturer shall submit to an authorised body for verification the quality system which he has set up for the…
For the application of the provisions of this chapter, army hospitals are considered to be public health establishments.
The medical file referred to in article R. 1112-2 must include:identification of the medical device: name, serial or batch number, name of the manufacturer or its authorised representative; - date of…
Doctors and dental surgeons who use medical devices on the list provided for in Article R. 5212-36, who carry out their activity outside a health or cosmetic surgery establishment, record the data nec…
Standby duty is paid at least once a year.
Placing on the market, whether free of charge or for a consideration, a tattoo product whose container or packaging does not bear one of the indications provided for in article R. 513-10-5 is punishab…
Repeated offences under this chapter are punishable in accordance witharticle 132-11 of the French Penal Code.
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