Article R5139-17
…r a period of forty years from the date of the last operation mentioned therein in order to be produced at the request of the competent authorities. This period is reduced to ten years for biological…
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Showing 1371–1380 of 11432 articles for “Art. CE 17-10-1990 n° 56991”
…r a period of forty years from the date of the last operation mentioned therein in order to be produced at the request of the competent authorities. This period is reduced to ten years for biological…
The expert reports provided for in article R. 5141-16 consist of a critical evaluation of the various trials carried out, taking into account the state of scientific knowledge at the time of submissio…
The period of practical experience provided for in article R. 5142-16 is reduced : 1° To one year for professionals whose higher education was completed as part of a five-year programme ; 2° To six mo…
No medical device may be placed on the market or put into service in France unless it complies with the essential health and safety requirements referred to in section 5 of this chapter which apply to…
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…
…ng information: 1° The date of the transaction ; 2° The name of the in vitro diagnostic medical device; 3° The quantity received or supplied, with batch numbers; 4° The name and address of the supplie…
For the application of this section, orders issued by the Minister for Health, on a proposal from the Director General of the National Agency for the Safety of Medicines and Health Products, shall spe…
Vigilance includes: 1° For user healthcare professionals mentioned in Article L. 5232-4, the reporting to the Agence française de sécurité sanitaire des produits de santé of any incident consisting of…
…sible for : 1° To ensure the consistency of the Agency's scientific strategy, taking into account recent developments both in methodology and in knowledge of the efficacy and safety of health products…
…without delay to the Director General of the Regional Health Agency and to the head of the support centre for the prevention of healthcare-associated infections mentioned in article R. 1413-83. He wi…
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