Décision du 11 mars 2015 portant suspension de mise sur le marché, d'importation et de distribution des kits d'examens dentaires fabriqués et mis sur le marché par la société CANGZHOU LANKANG MEDICAL INSTRUMENTS DEVELOPING
Jurisdiction | France |
ELI | https://www.legifrance.gouv.fr/eli/decision/2015/3/11/AFSM1500042S/jo/texte |
Enactment Date | 11 mars 2015 |
Record Number | JORFTEXT000030513532 |
Publication au Gazette officiel | JORF n°0095 du 23 avril 2015 |
Court | Ministère des affaires sociales, de la santé et des droits des femmes |
Date de publication | 23 avril 2015 |
Par décision en date du 11 mars 2015 du directeur général de l'Agence nationale de sécurité du médicament et des produits de santé (ANSM),
Considérant que la société CANGZHOU LANKANG MEDICAL INSTRUMENTS DEVELOPING fabrique et met sur le marché, des kits d'examens dentaires ; que ces produits, qui répondent à la définition du dispositif médical énoncée aux articles L. 5211-1 et R. 5211-1 du CSP, sont des dispositifs médicaux de classe I, mis sur le marché à l'état stérile ;
Considérant qu'en application de l'article R. 5211-39 du CSP, dans le cadre de la procédure de déclaration CE de conformité, le fabricant d'un dispositif médical doit notamment établir une documentation technique permettant d'évaluer la conformité du dispositif médical aux exigences essentielles de sécurité et de santé qui lui sont applicables ;
Considérant les éléments devant constituer la documentation technique tels que définis à l'article 1er de l'arrêté du 15 mars 2010, fixant les modalités d'application des procédures de certification de la conformité définies aux articles R. 5211-39 à R. 5211-52 du CSP, pris en application de l'article R. 5211-53 du même code ;
Considérant qu'en application de l'article R. 5211-65 du CSP, la société LOTUS GLOBAL est mandataire européen de la société CANGZHOU LANKANG MEDICAL INSTRUMENTS DEVELOPING pour les kits d'examens dentaires mis sur le marché par cette dernière ;
Considérant que la documentation technique fournie par courriel en date du 4 août 2014, par la société...
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