Article R5221-30-1
The bodies responsible for implementing the assessment procedures provided for in this Title shall be authorised for this purpose by a decision of the Director General of the Agence nationale de sécur…
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Showing 9811–9820 of 33456 articles for “Art. al. 3”
The bodies responsible for implementing the assessment procedures provided for in this Title shall be authorised for this purpose by a decision of the Director General of the Agence nationale de sécur…
The certificate is issued by the person responsible for transferring the second-hand medical device to the transferee.
The resale of a second-hand medical device is understood to mean any transfer of a medical device which is neither new nor refurbished within the meaning of 2° of article R. 5211-4. The second-hand re…
The certificate drawn up by the person responsible for the second-hand resale certifies that the second-hand in vitro diagnostic medical device has been serviced as part of the accreditation referred…
By way of derogation from the provisions of article R. 5212-35-4, where the second-hand medical device being transferred has never been put into service, the file is composed solely of the following e…
…in this chapter, in each establishment and organisation authorised in application of Article L. 1243-2 , including when they have an authorisation for import activity under Article R. 1245-7 and esta…
In all cases where the Agency's inspectors identify an infringement likely to result in criminal proceedings, the Agency's Director General will forward the report(s) referred to in Article L. 5411-2…
Prisoners admitted to hospital are considered as continuing to serve their sentence or, in the case of remand prisoners, as being remanded in custody.
…122-26 which does not lead to the threshold mentioned in the first paragraph of II of article R. 6123-161 being exceeded, as well as, regardless of the number of authorised units held by the holder, i…
The Director General of the Regional Health Agency may grant the dispensatory authorisation provided for in Article L. 6122-9-1 to one or more health establishments, with immediate effect and for a pe…
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