Article R5212-13
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…
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Showing 3191–3200 of 42414 articles for “Art. s. L. 641-13 & L. 643-8”
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…
User healthcare professionals working in one of the establishments mentioned in 4° of Article R. 5222-3 or in a blood transfusion establishment immediately report to the local reactovigilance correspo…
…the matters mentioned in 2°, 9° and 10° of Article R. 5322-11 are approved under the same conditions. Decisions relating to 14° of article R. 5322-11 are enforceable one month after they have been se…
The contract is for a maximum of five years; it may be revised by amendment.
The granting of a nuclear medicine activity authorisation is subject to compliance with the applicable provisions of Chapter III of Title III of Book III of Part One of this Code.
…Therapeutic procedures for cancerous pathologies involving the administration of radiopharmaceuticals.
…ients to be cared for if necessary, within a timeframe compatible with health protection requirements. II.-An "B" nuclear medicine authorisation may only be granted if the holder has: 1° A hospitalisa…
…his care differs from that usually provided at home in the complexity and frequency of the procedures.
The intervention team of the mobile emergency and resuscitation structure comprises at least one doctor, one nurse and one driver or pilot. The driver fulfils the conditions laid down in 1° of article…
…graphy camera or one positron emission tomography camera, possibly coupled with other imaging systems. If the holder of the authorisation has only one of these pieces of equipment, it must draw up an…
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