Article R5211-8
If a medical device is intended to be used in conjunction with another medical device, the classification rules apply separately to each device. Computer software controlling a device or influencing i…
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Showing 4261–4270 of 12694 articles for “Art. CAA Lyon 19-8-2021 n° 19LY01666”
If a medical device is intended to be used in conjunction with another medical device, the classification rules apply separately to each device. Computer software controlling a device or influencing i…
The penalty decision may, where appropriate, be accompanied by a daily penalty payment. This penalty payment is notified in accordance with the same procedural rules as the main sanction. The amount o…
Without prejudice to the provisions of Article R. 5221-9, in vitro diagnostic medical devices which comply with the standards relating to them and transposing the harmonised European standards, the re…
The authorisation is issued for a period of five years. At the request of the holder, submitted no later than two months before the normal expiry date, the initial authorisation is renewed for a perio…
The authorisation is issued for a period of five years. At the request of the holder, submitted no later than two months before the normal expiry date, the initial authorisation is renewed for a perio…
The provisions of Section 2 of Chapter VII of Title II of Book I of this Part are applicable to the inspectors of the Agence nationale de sécurité du médicament et des produits de santé.
I.-The examination by the Agence nationale de sécurité du médicament et des produits de santé of the application for a certificate of good manufacturing practice provided for in Article R. 5131-2 of t…
The Board of Directors meets at least three times a year when convened by its Chairman. The meeting is convened by right within thirty days of a request made by the Minister for Health, by the Chief E…
Service providers and equipment distributors are bound by professional secrecy. Secrecy covers not only what has been entrusted to them, but also what they have seen, read, heard, observed or understo…
The doctor responsible for medical information sends the medical board or conference and the establishment's representative the information required to analyse activity, both for the establishment as…
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