{"id":769,"date":"2024-01-17T16:52:10","date_gmt":"2024-01-17T08:52:10","guid":{"rendered":"https:\/\/consulting-hmk.com\/?p=769"},"modified":"2024-01-17T16:52:10","modified_gmt":"2024-01-17T08:52:10","slug":"medical-term-list","status":"publish","type":"post","link":"https:\/\/www.consulting-hmk.com\/fr\/medical-term-list\/","title":{"rendered":"Liste des termes m\u00e9dicaux"},"content":{"rendered":"\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
Chinois<\/span><\/td>\nAnglais<\/span><\/td>\n<\/tr>\n
\u4ea7\u54c1\u6280\u672f\u8d44\u6599<\/span><\/td>\nMat\u00e9riel technique sur les produits<\/span><\/td>\n<\/tr>\n
\u68c0\u9a8c\u4e2d\u5fc3<\/span><\/td>\nCentre de test<\/span><\/td>\n<\/tr>\n
\u6ce8\u518c\u68c0\u9a8c<\/span><\/td>\nTest d'inscription<\/span><\/td>\n<\/tr>\n
\u6ce8\u518c\u5355\u5143<\/span><\/td>\nUnit\u00e9 enregistr\u00e9e<\/span><\/td>\n<\/tr>\n
\u9884\u8bc4\u4ef7\u610f\u89c1<\/span><\/td>\nAvis de pr\u00e9-\u00e9valuation<\/span><\/td>\n<\/tr>\n
\u540c\u54c1\u79cd\u533b\u7597\u5668\u68b0<\/span><\/td>\nDispositif m\u00e9dical pr\u00e9dicat<\/span><\/td>\n<\/tr>\n
\u4e34\u5e8a\u8bd5\u9a8c\u673a\u6784<\/span><\/td>\nInstituts d'essais cliniques<\/span><\/td>\n<\/tr>\n
\u4f26\u7406\u59d4\u5458\u4f1a<\/span><\/td>\nComit\u00e9 d'\u00e9thique<\/span><\/td>\n<\/tr>\n
\u591a\u4e2d\u5fc3\u4e34\u5e8a\u8bd5\u9a8c<\/span><\/td>\nEssais cliniques multicentriques<\/span><\/td>\n<\/tr>\n
\u5f62\u5f0f\u5ba1\u67e5<\/span><\/td>\nExamen formel<\/span><\/td>\n<\/tr>\n
\u8ba4\u8bc1\u8bc1\u4e66<\/span><\/td>\nAutorit\u00e9 de certification, AC<\/span><\/td>\n<\/tr>\n
\u53d7\u7406\u901a\u77e5\u5355<\/span><\/td>\nAvis d'acceptation<\/span><\/td>\n<\/tr>\n
\u7f34\u8d39\u901a\u77e5\u4e66<\/span><\/td>\nFacture de paiement<\/span><\/td>\n<\/tr>\n
\u8865\u6b63\u8d44\u6599\u901a\u77e5\u4e66<\/span><\/td>\nLettre de carence<\/span><\/td>\n<\/tr>\n
\u4e0d\u4e88\u53d7\u7406\u901a\u77e5\u4e66<\/span><\/td>\nAvis de rejet<\/span><\/td>\n<\/tr>\n
\u53d1\u8865\u8981\u6c42<\/span><\/td>\nExigence d'un suppl\u00e9ment<\/span><\/td>\n<\/tr>\n
\u53d1\u8865\u540e\u54a8\u8be2<\/span><\/td>\nConsultation apr\u00e8s le rapport compl\u00e9mentaire<\/span><\/td>\n<\/tr>\n
\u73b0\u573a\u54a8\u8be2<\/span><\/td>\nConsultation sur place<\/span><\/td>\n<\/tr>\n
\u7f51\u4e0a\u54a8\u8be2<\/span><\/td>\nConsultation en ligne<\/span><\/td>\n<\/tr>\n
\u8865\u6b63\u8d44\u6599\u9884\u5ba1\u67e5<\/span><\/td>\nPr\u00e9-\u00e9valuation des documents suppl\u00e9mentaires<\/span><\/td>\n<\/tr>\n
\u4e13\u5bb6\u54a8\u8be2\u4f1a<\/span><\/td>\nR\u00e9union de consultation d'experts<\/span><\/td>\n<\/tr>\n
\u8bb8\u53ef\u4e8b\u9879\u53d8\u66f4<\/span><\/td>\nModifications des \u00e9l\u00e9ments d'autorisation<\/span><\/td>\n<\/tr>\n
\u767b\u8bb0\u4e8b\u9879\u53d8\u66f4<\/span><\/td>\nModifications des \u00e9l\u00e9ments du registre<\/span><\/td>\n<\/tr>\n
\u8bf4\u660e\u4e66\u66f4\u6539\u544a\u77e5<\/span><\/td>\nNotification sur les modifications des instructions d'utilisation<\/span><\/td>\n<\/tr>\n
\u5730\u533a\u6027\u7ba1\u7406\u4fe1\u606f<\/span><\/td>\nAdministration r\u00e9gionale<\/span><\/td>\n<\/tr>\n
\u7533\u62a5\u8d44\u6599\u76ee\u5f55<\/span><\/td>\nTable des mati\u00e8res de la soumission<\/span><\/td>\n<\/tr>\n
\u672f\u8bed\u7f29\u5199\u8bcd\u5217\u8868<\/span><\/td>\nListe des termes\/acronymes<\/span><\/td>\n<\/tr>\n
\u5668\u68b0\u5217\u8868<\/span><\/td>\nListe des dispositifs<\/span><\/td>\n<\/tr>\n
\u7b26\u5408\u6027\u9648\u8ff0\u8ba4\u8bc1\u58f0\u660e<\/span><\/td>\nD\u00e9clarations\/Certifications\/D\u00e9clarations de conformit\u00e9<\/span><\/td>\n<\/tr>\n
\u5668\u68b0\u63cf\u8ff0<\/span><\/td>\nDescription de l'appareil<\/span><\/td>\n<\/tr>\n
\u9002\u7528\u8303\u56f4\u548c\u6216\u9884\u671f\u7528\u9014\u53ca\u7981\u5fcc\u75c7<\/span><\/td>\nIndications d'utilisation et\/ou utilisation pr\u00e9vue et contre-indications<\/span><\/td>\n<\/tr>\n
\u5168\u7403\u4e0a\u5e02\u5386\u7a0b<\/span><\/td>\nHistorique du march\u00e9 mondial<\/span><\/td>\n<\/tr>\n
\u5b89\u5168\u6709\u6548\u57fa\u672c\u8981\u6c42(EP)\u6e05\u5355<\/span><\/td>\nListe de contr\u00f4le des principes essentiels (PE)<\/span><\/td>\n<\/tr>\n
\u975e\u4e34\u5e8a\u7814\u7a76\u8d44\u6599<\/span><\/td>\nPreuves non cliniques<\/span><\/td>\n<\/tr>\n
\u975e\u4e34\u5e8a\u7814\u7a76<\/span><\/td>\n\u00c9tudes non cliniques<\/span><\/td>\n<\/tr>\n
\u975e\u4e34\u5e8a\u7814\u7a76\u6587\u732e<\/span><\/td>\nBibliographie non clinique<\/span><\/td>\n<\/tr>\n
\u8d27\u67b6\u5bff\u547d\u548c\u5305\u88c5\u9a8c\u8bc1<\/span><\/td>\nP\u00e9riode d'expiration et validation du paquet<\/span><\/td>\n<\/tr>\n
\u4e34\u5e8a\u8bc1\u636e\u7efc\u8ff0<\/span><\/td>\nR\u00e9sum\u00e9 g\u00e9n\u00e9ral des donn\u00e9es cliniques<\/span><\/td>\n<\/tr>\n
\u4f26\u7406\u59d4\u5458\u4f1a\u6279\u51c6\u7684\u76f8\u5173\u6587\u4ef6<\/span><\/td>\nFormulaires de consentement \u00e9clair\u00e9 approuv\u00e9s par l'IRB<\/span><\/td>\n<\/tr>\n
\u76d1\u7ba1\u4fe1\u606f<\/span><\/td>\nInformations r\u00e9glementaires<\/span><\/td>\n<\/tr>\n
\u4ee3\u7406\u4eba<\/span><\/td>\nAgent<\/span><\/td>\n<\/tr>\n
\u6ce8\u518c\u4ee3\u7406\u4eba<\/span><\/td>\nAgent agr\u00e9\u00e9<\/span><\/td>\n<\/tr>\n
\u5883\u5185\u7533\u8bf7\u4eba<\/span><\/td>\nEntreprises manufacturi\u00e8res nationales<\/span><\/td>\n<\/tr>\n
\u5883\u5916\u7533\u8bf7\u4eba<\/span><\/td>\nEntreprises manufacturi\u00e8res d'outre-mer<\/span><\/td>\n<\/tr>\n
\u5f53\u5730\u7701\u5c40<\/span><\/td>\nBureau provincial local<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u6280\u672f\u5ba1\u8bc4\u4e2d\u5fc3\u54a8\u8be2\u767b\u8bb0\u8868<\/span><\/td>\nFormulaire d'inscription \u00e0 la consultation au CMDE<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u6807\u51c6\u7ba1\u7406\u7814\u7a76\u6240<\/span><\/td>\nCentre de supervision standardis\u00e9e<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u68c0\u9a8c\u8d44\u8d28<\/span><\/td>\nQualification des essais de dispositifs m\u00e9dicaux<\/span><\/td>\n<\/tr>\n
\u68c0\u6d4b\u4e2d\u5fc3\u627f\u68c0\u76ee\u5f55\u5e93<\/span><\/td>\nTest R\u00e9pertoire du centre de test<\/span><\/td>\n<\/tr>\n
\u9700\u8fdb\u884c\u4e34\u5e8a\u8bd5\u9a8c\u5ba1\u6279\u7684\u7b2c\u4e09\u7c7b\u533b\u7597\u5668\u68b0\u76ee\u5f55<\/span><\/td>\nCatalogue des dispositifs m\u00e9dicaux de classe III n\u00e9cessitant l'approbation d'essais cliniques<\/span><\/td>\n<\/tr>\n
\u540c\u54c1\u79cd\u6bd4\u5bf9<\/span><\/td>\nComparaison avec le dispositif m\u00e9dical pr\u00e9dicat\u00a0<\/span><\/td>\n<\/tr>\n
\u57fa\u672c\u7b49\u540c<\/span><\/td>\n\u00c9quivalent substantiel (SE)<\/span><\/td>\n<\/tr>\n
\u7533\u62a5\u4ea7\u54c1<\/span><\/td>\nObjet Produit<\/span><\/td>\n<\/tr>\n
\u4e34\u5e8a\u8bd5\u9a8c\u65b9\u6848<\/span><\/td>\nProtocole d'essai clinique<\/span><\/td>\n<\/tr>\n
\u5c0f\u6837\u672c\u53ef\u884c\u6027\u7814\u7a76<\/span><\/td>\n\u00c9tude de faisabilit\u00e9 sur un petit \u00e9chantillon<\/span><\/td>\n<\/tr>\n
\u4f26\u7406\u59d4\u5458\u4f1a\u610f\u89c1<\/span><\/td>\nAvis du comit\u00e9 d'\u00e9thique<\/span><\/td>\n<\/tr>\n
\u5b89\u5168\u6027\u8bc4\u4ef7\u65b9\u6cd5<\/span><\/td>\nM\u00e9thode d'\u00e9valuation de la s\u00e9curit\u00e9<\/span><\/td>\n<\/tr>\n
\u6709\u6548\u6027\u8bc4\u4ef7\u65b9\u6cd5<\/span><\/td>\nM\u00e9thode d'\u00e9valuation de l'efficacit\u00e9<\/span><\/td>\n<\/tr>\n
\u4e13\u5bb6\u54a8\u8be2\u4f1a\u8bae<\/span><\/td>\nR\u00e9union de consultation d'experts<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u76d1\u7763\u7ba1\u7406\u53f8<\/span><\/td>\nD\u00e9partement de la r\u00e9glementation des dispositifs m\u00e9dicaux<\/span><\/td>\n<\/tr>\n
\u4e2d\u56fd\u98df\u54c1\u836f\u54c1\u68c0\u5b9a\u7814\u7a76\u9662<\/span><\/td>\nInstituts nationaux de contr\u00f4le des aliments et des drogues<\/span><\/td>\n<\/tr>\n
\u56fd\u5bb6\u836f\u5178\u59d4\u5458\u4f1a<\/span><\/td>\nCommission de la pharmacop\u00e9e chinoise<\/span><\/td>\n<\/tr>\n
\u4e2d\u56fd\u98df\u54c1\u836f\u54c1\u56fd\u9645\u4ea4\u6d41\u4e2d\u5fc3<\/span><\/td>\nCentre chinois pour l'\u00e9change international d'aliments et de m\u00e9dicaments<\/span><\/td>\n<\/tr>\n
\u4e2d\u534e\u4eba\u6c11\u5171\u548c\u56fd\u836f\u5178<\/span><\/td>\nPharmacop\u00e9e de la R\u00e9publique populaire de Chine<\/span><\/td>\n<\/tr>\n
\u4e2d\u534e\u4eba\u6c11\u5171\u548c\u56fd\u6807\u51c6\u5316\u6cd5<\/span><\/td>\nLoi sur la normalisation de la R\u00e9publique populaire de Chine<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u8d28\u91cf\u62bd\u67e5\u68c0\u9a8c\u7ba1\u7406\u529e\u6cd5<\/span><\/td>\nles mesures administratives pour l'inspection par \u00e9chantillonnage de la qualit\u00e9 des dispositifs m\u00e9dicaux<\/span><\/td>\n<\/tr>\n
\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u91cd\u70b9\u5b9e\u9a8c\u5ba4\u7ba1\u7406\u529e\u6cd5<\/span><\/td>\nles mesures administratives pour les laboratoires cl\u00e9s de l'APMN<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u4ea7\u54c1\u51fa\u53e3\u9500\u552e\u8bc1\u660e<\/span><\/td>\nLicence d'exportation et de vente de dispositifs m\u00e9dicaux<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u751f\u4ea7\u8bb8\u53ef\u8bc1<\/span><\/td>\nCertificat de fabrication d'un dispositif m\u00e9dical<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u751f\u4ea7\u5907\u6848\u51ed\u8bc1<\/span><\/td>\nCertificat de d\u00e9p\u00f4t de fabrication de dispositifs m\u00e9dicaux<\/span><\/td>\n<\/tr>\n
\u5185\u90e8\u6838\u67e5<\/span><\/td>\nV\u00e9rification interne<\/span><\/td>\n<\/tr>\n
\u7f51\u7edc\u6838\u9a8c<\/span><\/td>\nV\u00e9rification en ligne<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u6ce8\u518c\u7533\u62a5\u8d44\u6599\u8981\u6c42\u548c\u6279\u51c6\u8bc1\u660e\u6587\u4ef6\u683c\u5f0f\u7684\u516c\u544a<\/span><\/td>\nAnnonce sur les exigences relatives aux dossiers de demande d'enregistrement des dispositifs m\u00e9dicaux et au format des documents d'approbation<\/span><\/td>\n<\/tr>\n
\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u6ce8\u518c\u7533\u62a5\u8d44\u6599\u8981\u6c42\u548c\u6279\u51c6\u8bc1\u660e\u6587\u4ef6\u683c\u5f0f\u7684\u516c\u544a<\/span><\/td>\nAnnonce sur les exigences relatives aux dossiers de demande d'enregistrement des r\u00e9actifs de diagnostic in vitro et au format des documents d'approbation<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u5f3a\u5236\u6027\u884c\u4e1a\u6807\u51c6<\/span><\/td>\nNormes industrielles obligatoires pour les dispositifs m\u00e9dicaux<\/span><\/td>\n<\/tr>\n
\u5f3a\u5236\u6027\u884c\u4e1a\u6807\u51c6\u4f53\u7cfb<\/span><\/td>\nSyst\u00e8me de normes industrielles obligatoires<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u5b9a\u671f\u98ce\u9669\u8bc4\u4ef7\u62a5\u544a<\/span><\/td>\nRapports p\u00e9riodiques d'\u00e9valuation des risques des dispositifs m\u00e9dicaux<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u72ec\u7acb\u8f6f\u4ef6\u73b0\u573a\u68c0\u67e5\u6307\u5bfc\u539f\u5219<\/span><\/td>\nGuide pour l'inspection sur site des logiciels ind\u00e9pendants annex\u00e9s aux bonnes pratiques de fabrication des dispositifs m\u00e9dicaux<\/span><\/td>\n<\/tr>\n
\u9ad8\u503c\u533b\u7528\u8017\u6750<\/span><\/td>\nConsommables m\u00e9dicaux de grande valeur<\/span><\/td>\n<\/tr>\n
\u96c6\u4e2d\u91c7\u8d2d<\/span><\/td>\nApprovisionnement centralis\u00e9<\/span><\/td>\n<\/tr>\n
\u65e0\u83cc\u548c\u690d\u5165\u6027\u533b\u7597\u5668\u68b0\u76d1\u7763\u68c0\u67e5<\/span><\/td>\nSupervision et inspection des dispositifs m\u00e9dicaux st\u00e9riles et implantables<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u6ce8\u518c\u4eba<\/span><\/td>\nRegistraires de dispositifs m\u00e9dicaux<\/span><\/td>\n<\/tr>\n
\u56fd\u5bb6\u533b\u7597\u5668\u68b0\u4e0d\u826f\u4e8b\u4ef6\u76d1\u6d4b\u4fe1\u606f\u7cfb\u7edf<\/span><\/td>\nle syst\u00e8me national d'information sur la surveillance des \u00e9v\u00e9nements ind\u00e9sirables li\u00e9s aux dispositifs m\u00e9dicaux<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u4e0d\u826f\u4e8b\u4ef6\u4fe1\u606f\u901a\u62a5<\/span><\/td>\nNotification d'\u00e9v\u00e9nements ind\u00e9sirables concernant des dispositifs m\u00e9dicaux<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u8b66\u6212\u5feb\u8baf<\/span><\/td>\nPharmacovigilance des dispositifs m\u00e9dicaux Expresses<\/span><\/td>\n<\/tr>\n
\u53ef\u7591\u533b\u7597\u5668\u68b0\u4e0d\u826f\u4e8b\u4ef6\u62a5\u544a<\/span><\/td>\nSuspicion d'\u00e9v\u00e9nements ind\u00e9sirables li\u00e9s \u00e0 des dispositifs m\u00e9dicaux<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u62d3\u5c55\u6027\u4e34\u5e8a\u8bd5\u9a8c\u7ba1\u7406\u89c4\u5b9a<\/span><\/td>\nR\u00e8glement relatif \u00e0 l'administration des essais cliniques \u00e9tendus de dispositifs m\u00e9dicaux<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u552f\u4e00\u6807\u8bc6\u6570\u636e\u5e93<\/span><\/td>\nBase de donn\u00e9es d'identification unique des dispositifs m\u00e9dicaux<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u901a\u7528\u540d\u79f0\u547d\u540d<\/span><\/td>\nNomenclature des noms communs des dispositifs m\u00e9dicaux<\/span><\/td>\n<\/tr>\n
\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40<\/span><\/td>\nAdministration nationale des produits m\u00e9dicaux, NMPA<\/span><\/td>\n<\/tr>\n
\u56fd\u5bb6\u536b\u751f\u5065\u5eb7\u59d4<\/span><\/td>\nCommission nationale de la sant\u00e9 NHC<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u6807\u51c6\u7ba1\u7406\u4e2d\u5fc3<\/span><\/td>\nCentre de gestion des normes relatives aux dispositifs m\u00e9dicaux<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u6280\u672f\u5ba1\u8bc4\u4e2d\u5fc3<\/span><\/td>\nCentre d'\u00e9valuation des dispositifs m\u00e9dicaux, CMDE<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u76d1\u7763\u7ba1\u7406\u6761\u4f8b<\/span><\/td>\nR\u00e8glement relatif \u00e0 la surveillance et \u00e0 l'administration des dispositifs m\u00e9dicaux<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u6ce8\u518c\u7ba1\u7406\u529e\u6cd5<\/span><\/td>\nDispositions relatives \u00e0 l'enregistrement des dispositifs m\u00e9dicaux<\/span><\/td>\n<\/tr>\n
\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u6ce8\u518c\u7ba1\u7406\u529e\u6cd5<\/span><\/td>\nDispositions relatives \u00e0 l'enregistrement des r\u00e9actifs de diagnostic in vitro<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u8bf4\u660e\u4e66\u548c\u6807\u7b7e\u7ba1\u7406\u89c4\u5b9a<\/span><\/td>\nDispositions relatives aux instructions et aux \u00e9tiquettes des dispositifs m\u00e9dicaux<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u6807\u51c6\u7ba1\u7406\u529e\u6cd5<\/span><\/td>\nDispositions relatives aux normes sur les dispositifs m\u00e9dicaux<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u5206\u7c7b\u89c4\u5219<\/span><\/td>\nR\u00e8gles de classification des dispositifs m\u00e9dicaux<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u4e34\u5e8a\u8bd5\u9a8c\u8d28\u91cf\u7ba1\u7406\u89c4\u8303<\/span><\/td>\nBonnes pratiques cliniques pour les dispositifs m\u00e9dicaux<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303<\/span><\/td>\nDispositifs m\u00e9dicaux GMP<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u4e0d\u826f\u4e8b\u4ef6\u76d1\u6d4b\u548c\u518d\u8bc4\u4ef7\u7ba1\u7406\u529e\u6cd5<\/span><\/td>\nDispositions relatives au suivi et \u00e0 la r\u00e9\u00e9valuation des \u00e9v\u00e9nements ind\u00e9sirables des dispositifs m\u00e9dicaux<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u8d28\u91cf\u62bd\u67e5\u68c0\u9a8c\u7ba1\u7406\u529e\u6cd5<\/span><\/td>\nMesures administratives pour l'inspection par \u00e9chantillonnage de la qualit\u00e9 des dispositifs m\u00e9dicaux<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u6ce8\u518c\u4eba\u5236\u5ea6<\/span><\/td>\nSyst\u00e8me d'enregistrement des dispositifs m\u00e9dicaux<\/span><\/td>\n<\/tr>\n
\u521b\u65b0\u533b\u7597\u5668\u68b0\u7279\u522b\u5ba1\u67e5\u7a0b\u5e8f<\/span><\/td>\nProc\u00e9dures d'examen sp\u00e9cial des dispositifs m\u00e9dicaux innovants<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u9644\u6761\u4ef6\u6279\u51c6\u4e0a\u5e02<\/span><\/td>\nAutorisation conditionnelle de mise sur le march\u00e9 de dispositifs m\u00e9dicaux<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u4ea7\u54c1\u6ce8\u518c\u9879\u76ee\u7acb\u5377\u5ba1\u67e5<\/span><\/td>\nExamen des \u00e9l\u00e9ments d'enregistrement d'un dispositif m\u00e9dical<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u6ce8\u518c\u7535\u5b50\u7533\u62a5\u4fe1\u606f\u5316\u7cfb\u7edf<\/span><\/td>\nSyst\u00e8me de soumission \u00e9lectronique des produits r\u00e9glement\u00e9s (eRPS)<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u6ce8\u518c\u7535\u5b50\u7533\u62a5<\/span><\/td>\nApplication \u00e9lectronique de l'enregistrement des dispositifs m\u00e9dicaux<\/span><\/td>\n<\/tr>\n
\u9996\u6b21\u6ce8\u518c<\/span><\/td>\nEnregistrements initiaux<\/span><\/td>\n<\/tr>\n
\u5ef6\u7eed\u6ce8\u518c<\/span><\/td>\nRenouvellement de l'enregistrement<\/span><\/td>\n<\/tr>\n
\u53d8\u66f4\u6ce8\u518c<\/span><\/td>\nModifications de l'enregistrement<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u68c0\u9a8c\u68c0\u6d4b\u673a\u6784<\/span><\/td>\nOrganismes d'inspection et d'essai des dispositifs m\u00e9dicaux<\/span><\/td>\n<\/tr>\n
\u4e34\u5e8a\u8bd5\u9a8c\u5ba1\u8bc4\u7533\u8bf7<\/span><\/td>\nDemande d'examen et d'approbation d'un essai clinique<\/span><\/td>\n<\/tr>\n
\u514d\u4e8e\u8fdb\u884c\u4e34\u5e8a\u8bd5\u9a8c\u533b\u7597\u5668\u68b0\u76ee\u5f55<\/span><\/td>\nCatalogues des dispositifs m\u00e9dicaux exempt\u00e9s d'essais cliniques<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u6ce8\u518c\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u6838\u67e5<\/span><\/td>\nV\u00e9rification du syst\u00e8me de gestion de la qualit\u00e9 pour l'enregistrement des dispositifs m\u00e9dicaux<\/span><\/td>\n<\/tr>\n
\u751f\u4ea7\u73b0\u573a\u68c0\u67e5<\/span><\/td>\nInspections des sites de production<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u5b89\u5168\u548c\u6027\u80fd\u57fa\u672c\u539f\u7406<\/span><\/td>\nPrincipes fondamentaux pour la s\u00e9curit\u00e9 et la performance des dispositifs m\u00e9dicaux<\/span><\/td>\n<\/tr>\n
\u7533\u62a5\u8d44\u6599<\/span><\/td>\nDossiers de candidature<\/span><\/td>\n<\/tr>\n
\u6ce8\u518c\u5ba1\u8bc4\u5ba1\u6279<\/span><\/td>\nExamen et approbation de l'enregistrement<\/span><\/td>\n<\/tr>\n
\u56fd\u5bb6\u533b\u7597\u5668\u68b0\u4e0d\u826f\u4e8b\u4ef6\u76d1\u6d4b\u5e74\u5ea6\u62a5\u544a<\/span><\/td>\nRapport annuel sur la surveillance nationale des \u00e9v\u00e9nements ind\u00e9sirables li\u00e9s aux dispositifs m\u00e9dicaux<\/span><\/td>\n<\/tr>\n
\u56fd\u4ea7\u5668\u68b0<\/span><\/td>\nDispositif domestique<\/span><\/td>\n<\/tr>\n
\u8fdb\u53e3\u5668\u68b0<\/span><\/td>\nDispositif import\u00e9<\/span><\/td>\n<\/tr>\n
\u5916\u6e90\u56e0\u5b50<\/span><\/td>\nAgents adventices<\/span><\/td>\n<\/tr>\n
\u9633\u6027\u5bf9\u7167\u8bd5\u9a8c<\/span><\/td>\nEssais contr\u00f4l\u00e9s actifs<\/span><\/td>\n<\/tr>\n
\u7533\u8bf7\u4eba<\/span><\/td>\nDemandeur<\/span><\/td>\n<\/tr>\n
\u7b80\u8981\u603b\u7ed3<\/span><\/td>\nBref r\u00e9sum\u00e9<\/span><\/td>\n<\/tr>\n
\u83b7\u76ca\u4e0e\u98ce\u9669\u7ed3\u8bba<\/span><\/td>\nConclusions sur les avantages et les risques<\/span><\/td>\n<\/tr>\n
\u751f\u7269\u836f\u5242\u5b66\u7814\u7a76<\/span><\/td>\n\u00c9tudes biopharmaceutiques<\/span><\/td>\n<\/tr>\n
\u751f\u7269\u5229\u7528\u5ea6<\/span><\/td>\nBiodisponibilit\u00e9<\/span><\/td>\n<\/tr>\n
\u751f\u7269\u7b49\u6548\u6027<\/span><\/td>\nBio\u00e9quivalence<\/span><\/td>\n<\/tr>\n
\u4e34\u5e8a\u7efc\u8ff0<\/span><\/td>\nAper\u00e7u clinique<\/span><\/td>\n<\/tr>\n
\u4e34\u5e8a\u603b\u7ed3<\/span><\/td>\nR\u00e9sum\u00e9 clinique<\/span><\/td>\n<\/tr>\n
\u4e34\u5e8a\u7814\u7a76\u62a5\u544a<\/span><\/td>\nRapports d'\u00e9tudes cliniques<\/span><\/td>\n<\/tr>\n
\u4e34\u5e8a\u6709\u6548\u6027<\/span><\/td>\nEfficacit\u00e9 clinique<\/span><\/td>\n<\/tr>\n
\u4e34\u5e8a\u5b89\u5168\u6027<\/span><\/td>\nS\u00e9curit\u00e9 clinique<\/span><\/td>\n<\/tr>\n
\u4e34\u5e8a\u836f\u7406\u5b66<\/span><\/td>\nPharmacologie clinique<\/span><\/td>\n<\/tr>\n
\u63a7\u5236\u7b56\u7565<\/span><\/td>\nStrat\u00e9gie de contr\u00f4le<\/span><\/td>\n<\/tr>\n
\u836f\u5178\u5404\u8bba<\/span><\/td>\nMonographies officinales<\/span><\/td>\n<\/tr>\n
\u5173\u952e\u6b65\u9aa4<\/span><\/td>\n\u00c9tapes critiques<\/span><\/td>\n<\/tr>\n
\u836f\u5178<\/span><\/td>\nCompendium<\/span><\/td>\n<\/tr>\n
\u5bf9\u7167\u4e34\u5e8a\u8bd5\u9a8c<\/span><\/td>\nEssais cliniques contr\u00f4l\u00e9s<\/span><\/td>\n<\/tr>\n
\u7269\u6599\u63a7\u5236<\/span><\/td>\nContr\u00f4le des mat\u00e9riaux<\/span><\/td>\n<\/tr>\n
\u901a\u7528\u6280\u672f\u6587\u6863<\/span><\/td>\nDocument technique commun<\/span><\/td>\n<\/tr>\n
\u6d53\u5ea6<\/span><\/td>\nConcentration<\/span><\/td>\n<\/tr>\n
\u5305\u88c5\u7cfb\u7edf<\/span><\/td>\nSyst\u00e8me de fermeture des conteneurs<\/span><\/td>\n<\/tr>\n
\u5236\u5242<\/span><\/td>\nProduit pharmaceutique<\/span><\/td>\n<\/tr>\n
\u53cc\u76f2\u3001\u9633\u6027\u5bf9\u7167\u8bd5\u9a8c<\/span><\/td>\nEssai contr\u00f4l\u00e9 actif en double aveugle<\/span><\/td>\n<\/tr>\n
\u539f\u6599\u836f\/\u539f\u6db2<\/span><\/td>\nSubstance m\u00e9dicamenteuse<\/span><\/td>\n<\/tr>\n
\u5242\u578b<\/span><\/td>\nForme posologique<\/span><\/td>\n<\/tr>\n
\u53cc\u76f2\u3001\u5b89\u6170\u5242\u5bf9\u7167\u8bd5\u9a8c<\/span><\/td>\nEssai en double aveugle, contr\u00f4l\u00e9 par placebo<\/span><\/td>\n<\/tr>\n
\u8bbe\u5907<\/span><\/td>\nEquipement<\/span><\/td>\n<\/tr>\n
\u8f85\u6599<\/span><\/td>\nExcipient<\/span><\/td>\n<\/tr>\n
\u6709\u6548\u6027<\/span><\/td>\nEfficacit\u00e9<\/span><\/td>\n<\/tr>\n
\u8bbe\u65bd<\/span><\/td>\nFacilit\u00e9<\/span><\/td>\n<\/tr>\n
\u7ed3\u679c<\/span><\/td>\nR\u00e9sultats<\/span><\/td>\n<\/tr>\n
\u6307\u5357<\/span><\/td>\nOrientations<\/span><\/td>\n<\/tr>\n
\u7c92\u5ea6\u6587\u4ef6<\/span><\/td>\nDocument de granularit\u00e9<\/span><\/td>\n<\/tr>\n
\u57fa\u672c\u4fe1\u606f<\/span><\/td>\nInformations g\u00e9n\u00e9rales<\/span><\/td>\n<\/tr>\n
\u901a\u7528\u672f\u8bed\u8868<\/span><\/td>\nGlossaire g\u00e9n\u00e9ral<\/span><\/td>\n<\/tr>\n
\u4e00\u822c\u539f\u5219<\/span><\/td>\nPrincipes g\u00e9n\u00e9raux<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>","protected":false},"excerpt":{"rendered":"

Chinese English \u4ea7\u54c1\u6280\u672f\u8d44\u6599 Product Technical Materials \u68c0\u9a8c\u4e2d\u5fc3 Testing Center \u6ce8\u518c\u68c0\u9a8c Registration Test \u6ce8\u518c\u5355\u5143 Registered Unit \u9884\u8bc4\u4ef7\u610f\u89c1 Pre-evaluation Opinions \u540c\u54c1\u79cd\u533b\u7597\u5668\u68b0 Predicate Medical Device \u4e34\u5e8a\u8bd5\u9a8c\u673a\u6784 Clinical Trial\u00a0Institutes \u4f26\u7406\u59d4\u5458\u4f1a Ethics Committee \u591a\u4e2d\u5fc3\u4e34\u5e8a\u8bd5\u9a8c Multi-center Clinical Trials \u5f62\u5f0f\u5ba1\u67e5 Formal Examination \u8ba4\u8bc1\u8bc1\u4e66 Certificate Authority, CA \u53d7\u7406\u901a\u77e5\u5355 Notice of Acceptance \u7f34\u8d39\u901a\u77e5\u4e66 Bill of Payment \u8865\u6b63\u8d44\u6599\u901a\u77e5\u4e66 Deficiency Letter \u4e0d\u4e88\u53d7\u7406\u901a\u77e5\u4e66 Notice of Rejection \u53d1\u8865\u8981\u6c42 […]<\/p>","protected":false},"author":4,"featured_media":770,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[70],"tags":[201,202],"acf":[],"_links":{"self":[{"href":"https:\/\/www.consulting-hmk.com\/fr\/wp-json\/wp\/v2\/posts\/769"}],"collection":[{"href":"https:\/\/www.consulting-hmk.com\/fr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.consulting-hmk.com\/fr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.consulting-hmk.com\/fr\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/www.consulting-hmk.com\/fr\/wp-json\/wp\/v2\/comments?post=769"}],"version-history":[{"count":0,"href":"https:\/\/www.consulting-hmk.com\/fr\/wp-json\/wp\/v2\/posts\/769\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.consulting-hmk.com\/fr\/wp-json\/wp\/v2\/media\/770"}],"wp:attachment":[{"href":"https:\/\/www.consulting-hmk.com\/fr\/wp-json\/wp\/v2\/media?parent=769"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.consulting-hmk.com\/fr\/wp-json\/wp\/v2\/categories?post=769"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.consulting-hmk.com\/fr\/wp-json\/wp\/v2\/tags?post=769"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}