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Showing 6731–6740 of 65809 articles for “Art. R 212-1/2”
The conditions for implementing the essential requirements defined in this section are specified, on a proposal from the Director General of the Agence nationale de sécurité du médicament et des produ…
As part of the EC verification procedure, the manufacturer shall submit to an authorized body for inspection devices manufactured in conformity with an approved type as described in an EC type-examina…
As part of the procedure applicable to in vitro diagnostic medical devices undergoing an assessment of their performance, the manufacturer must draw up a declaration containing the data enabling the d…
As part of the EC declaration of conformity procedure, the manufacturer shall draw up technical documentation making it possible to assess the conformity of the in vitro diagnostic medical device with…
As part of the EC type-examination procedure, the manufacturer must submit to an authorized body for examination a representative sample, known as the type, of the production envisaged in order that t…
On the basis of a contract that complies with good hospital pharmacy practice, the principles of which are laid down by order of the Minister for Health, and after obtaining the opinion of the regiona…
The authorisation holder shall carry out the assessment referred to in Article L. 6122-5, in accordance with the conditions laid down in this section.The purpose of this evaluation is to check that th…
Applications for authorisation and, where appropriate, for renewal of authorisation are sent to the Director General of the Regional Health Agency by electronic means or by registered post with acknow…
Evaluation indicators relating to healthcare activities or heavy equipment are defined by order of the Director General of the Regional Health Agency or, where there is an inter-regional health plan,…
The holder of the "bariatric surgery" authorisation is organised in such a way as to be able to provide each patient with an opinion validating the surgical management, based on multidisciplinary cons…
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