Article R5221-19
…aration of conformity, full quality assurance system; 4° EC type examination ; 5° EC verification ; 6° EC declaration of conformity, production quality assurance.
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Showing 7461–7470 of 14454 articles for “Art. 6 nov. 2001”
…aration of conformity, full quality assurance system; 4° EC type examination ; 5° EC verification ; 6° EC declaration of conformity, production quality assurance.
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…
An order of the Minister for Health, issued on a proposal from the Director General of the Agence nationale de sécurité du médicament et des produits de santé, specifies the conditions for applying th…
I.-For the purposes of article L. 162-30-5 of the French Social Security Code, the following are considered to be exceptional: 1° A graft with rare medical indications which, in the indication in ques…
The authorisation shall specify: 1° The organs or tissues or vascularised tissues for which it is granted; 2° The indication or situation concerned; 3° Whether the activity concerns children, adults a…
The national committee provided for in article L. 162-30-5 of the Social Security Code comprises: 1° The Director General of Healthcare or his representative; 2° The Director General of Health or his…
The health care establishment authorised to carry out the activity of exceptional organ or tissue transplantation or composite vascularised tissue transplantation must be able to ensure its implementa…
A visit to check compliance with the safety commitments and rules is carried out by the Regional Health Agency no later than two months after the implementation of the exceptional transplant activity.…
…eipt, by electronic means, to the secretariat of the national committee provided for in article L. 162-30-5 of the Social Security Code and, where appropriate, sends its opinion on the application wit…
…of the self-employed activities of statutory full-time practitioners as provided for in article L. 6154-1.
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