{"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\/pt\/medical-term-list\/","title":{"rendered":"Lista de termos m\u00e9dicos"},"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
Chin\u00eas<\/span><\/td>\nIngl\u00eas<\/span><\/td>\n<\/tr>\n
\u4ea7\u54c1\u6280\u672f\u8d44\u6599<\/span><\/td>\nMateriais t\u00e9cnicos de produtos<\/span><\/td>\n<\/tr>\n
\u68c0\u9a8c\u4e2d\u5fc3<\/span><\/td>\nCentro de testes<\/span><\/td>\n<\/tr>\n
\u6ce8\u518c\u68c0\u9a8c<\/span><\/td>\nTeste de registo<\/span><\/td>\n<\/tr>\n
\u6ce8\u518c\u5355\u5143<\/span><\/td>\nUnidade registada<\/span><\/td>\n<\/tr>\n
\u9884\u8bc4\u4ef7\u610f\u89c1<\/span><\/td>\nPareceres de pr\u00e9-avalia\u00e7\u00e3o<\/span><\/td>\n<\/tr>\n
\u540c\u54c1\u79cd\u533b\u7597\u5668\u68b0<\/span><\/td>\nDispositivo m\u00e9dico predeterminado<\/span><\/td>\n<\/tr>\n
\u4e34\u5e8a\u8bd5\u9a8c\u673a\u6784<\/span><\/td>\nInstitutos de Ensaios Cl\u00ednicos<\/span><\/td>\n<\/tr>\n
\u4f26\u7406\u59d4\u5458\u4f1a<\/span><\/td>\nComit\u00e9 de \u00c9tica<\/span><\/td>\n<\/tr>\n
\u591a\u4e2d\u5fc3\u4e34\u5e8a\u8bd5\u9a8c<\/span><\/td>\nEnsaios cl\u00ednicos multic\u00eantricos<\/span><\/td>\n<\/tr>\n
\u5f62\u5f0f\u5ba1\u67e5<\/span><\/td>\nExame formal<\/span><\/td>\n<\/tr>\n
\u8ba4\u8bc1\u8bc1\u4e66<\/span><\/td>\nAutoridade de Certifica\u00e7\u00e3o, AC<\/span><\/td>\n<\/tr>\n
\u53d7\u7406\u901a\u77e5\u5355<\/span><\/td>\nAviso de aceita\u00e7\u00e3o<\/span><\/td>\n<\/tr>\n
\u7f34\u8d39\u901a\u77e5\u4e66<\/span><\/td>\nFatura de pagamento<\/span><\/td>\n<\/tr>\n
\u8865\u6b63\u8d44\u6599\u901a\u77e5\u4e66<\/span><\/td>\nCarta de Defici\u00eancia<\/span><\/td>\n<\/tr>\n
\u4e0d\u4e88\u53d7\u7406\u901a\u77e5\u4e66<\/span><\/td>\nAviso de rejei\u00e7\u00e3o<\/span><\/td>\n<\/tr>\n
\u53d1\u8865\u8981\u6c42<\/span><\/td>\nExig\u00eancia de suplemento<\/span><\/td>\n<\/tr>\n
\u53d1\u8865\u540e\u54a8\u8be2<\/span><\/td>\nConsulta ap\u00f3s a consulta suplementar<\/span><\/td>\n<\/tr>\n
\u73b0\u573a\u54a8\u8be2<\/span><\/td>\nConsulta no local<\/span><\/td>\n<\/tr>\n
\u7f51\u4e0a\u54a8\u8be2<\/span><\/td>\nConsulta em linha<\/span><\/td>\n<\/tr>\n
\u8865\u6b63\u8d44\u6599\u9884\u5ba1\u67e5<\/span><\/td>\nPr\u00e9-avalia\u00e7\u00e3o de documentos suplementares<\/span><\/td>\n<\/tr>\n
\u4e13\u5bb6\u54a8\u8be2\u4f1a<\/span><\/td>\nReuni\u00e3o de consulta de peritos<\/span><\/td>\n<\/tr>\n
\u8bb8\u53ef\u4e8b\u9879\u53d8\u66f4<\/span><\/td>\nAltera\u00e7\u00f5es de itens de autoriza\u00e7\u00e3o<\/span><\/td>\n<\/tr>\n
\u767b\u8bb0\u4e8b\u9879\u53d8\u66f4<\/span><\/td>\nAltera\u00e7\u00f5es de itens de registo<\/span><\/td>\n<\/tr>\n
\u8bf4\u660e\u4e66\u66f4\u6539\u544a\u77e5<\/span><\/td>\nNotifica\u00e7\u00e3o de altera\u00e7\u00f5es ao manual de instru\u00e7\u00f5es de utiliza\u00e7\u00e3o<\/span><\/td>\n<\/tr>\n
\u5730\u533a\u6027\u7ba1\u7406\u4fe1\u606f<\/span><\/td>\nAdministrativo Regional<\/span><\/td>\n<\/tr>\n
\u7533\u62a5\u8d44\u6599\u76ee\u5f55<\/span><\/td>\nApresenta\u00e7\u00e3o \u00cdndice<\/span><\/td>\n<\/tr>\n
\u672f\u8bed\u7f29\u5199\u8bcd\u5217\u8868<\/span><\/td>\nLista de termos\/acr\u00f3nimos<\/span><\/td>\n<\/tr>\n
\u5668\u68b0\u5217\u8868<\/span><\/td>\nListagem do(s) dispositivo(s)<\/span><\/td>\n<\/tr>\n
\u7b26\u5408\u6027\u9648\u8ff0\u8ba4\u8bc1\u58f0\u660e<\/span><\/td>\nDeclara\u00e7\u00f5es\/Certifica\u00e7\u00f5es\/Declara\u00e7\u00f5es de Conformidade<\/span><\/td>\n<\/tr>\n
\u5668\u68b0\u63cf\u8ff0<\/span><\/td>\nDescri\u00e7\u00e3o do dispositivo<\/span><\/td>\n<\/tr>\n
\u9002\u7528\u8303\u56f4\u548c\u6216\u9884\u671f\u7528\u9014\u53ca\u7981\u5fcc\u75c7<\/span><\/td>\nIndica\u00e7\u00f5es de utiliza\u00e7\u00e3o e\/ou utiliza\u00e7\u00e3o prevista e contra-indica\u00e7\u00f5es<\/span><\/td>\n<\/tr>\n
\u5168\u7403\u4e0a\u5e02\u5386\u7a0b<\/span><\/td>\nHist\u00f3ria do mercado global<\/span><\/td>\n<\/tr>\n
\u5b89\u5168\u6709\u6548\u57fa\u672c\u8981\u6c42(EP)\u6e05\u5355<\/span><\/td>\nLista de controlo dos Princ\u00edpios Essenciais (PE)<\/span><\/td>\n<\/tr>\n
\u975e\u4e34\u5e8a\u7814\u7a76\u8d44\u6599<\/span><\/td>\nEvid\u00eancias n\u00e3o cl\u00ednicas<\/span><\/td>\n<\/tr>\n
\u975e\u4e34\u5e8a\u7814\u7a76<\/span><\/td>\nEstudos n\u00e3o cl\u00ednicos<\/span><\/td>\n<\/tr>\n
\u975e\u4e34\u5e8a\u7814\u7a76\u6587\u732e<\/span><\/td>\nBibliografia n\u00e3o cl\u00ednica<\/span><\/td>\n<\/tr>\n
\u8d27\u67b6\u5bff\u547d\u548c\u5305\u88c5\u9a8c\u8bc1<\/span><\/td>\nPer\u00edodo de expira\u00e7\u00e3o e valida\u00e7\u00e3o de pacotes<\/span><\/td>\n<\/tr>\n
\u4e34\u5e8a\u8bc1\u636e\u7efc\u8ff0<\/span><\/td>\nResumo geral das evid\u00eancias cl\u00ednicas<\/span><\/td>\n<\/tr>\n
\u4f26\u7406\u59d4\u5458\u4f1a\u6279\u51c6\u7684\u76f8\u5173\u6587\u4ef6<\/span><\/td>\nFormul\u00e1rios de consentimento informado aprovados pelo IRB<\/span><\/td>\n<\/tr>\n
\u76d1\u7ba1\u4fe1\u606f<\/span><\/td>\nInforma\u00e7\u00f5es regulamentares<\/span><\/td>\n<\/tr>\n
\u4ee3\u7406\u4eba<\/span><\/td>\nAgente<\/span><\/td>\n<\/tr>\n
\u6ce8\u518c\u4ee3\u7406\u4eba<\/span><\/td>\nAgente registado<\/span><\/td>\n<\/tr>\n
\u5883\u5185\u7533\u8bf7\u4eba<\/span><\/td>\nEmpresas transformadoras nacionais<\/span><\/td>\n<\/tr>\n
\u5883\u5916\u7533\u8bf7\u4eba<\/span><\/td>\nEmpresas transformadoras ultramarinas<\/span><\/td>\n<\/tr>\n
\u5f53\u5730\u7701\u5c40<\/span><\/td>\nGabinete Provincial local<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u6280\u672f\u5ba1\u8bc4\u4e2d\u5fc3\u54a8\u8be2\u767b\u8bb0\u8868<\/span><\/td>\nFormul\u00e1rio de inscri\u00e7\u00e3o para consulta na CMDE<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u6807\u51c6\u7ba1\u7406\u7814\u7a76\u6240<\/span><\/td>\nCentro de Supervis\u00e3o Padronizada<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u68c0\u9a8c\u8d44\u8d28<\/span><\/td>\nQualifica\u00e7\u00e3o de testes de dispositivos m\u00e9dicos<\/span><\/td>\n<\/tr>\n
\u68c0\u6d4b\u4e2d\u5fc3\u627f\u68c0\u76ee\u5f55\u5e93<\/span><\/td>\nTeste Diret\u00f3rio do centro de testes<\/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>\nCat\u00e1logo de dispositivos m\u00e9dicos da classe III que requerem a aprova\u00e7\u00e3o de ensaios cl\u00ednicos<\/span><\/td>\n<\/tr>\n
\u540c\u54c1\u79cd\u6bd4\u5bf9<\/span><\/td>\nCompara\u00e7\u00e3o com o dispositivo m\u00e9dico de refer\u00eancia\u00a0<\/span><\/td>\n<\/tr>\n
\u57fa\u672c\u7b49\u540c<\/span><\/td>\nEquivalente substancial (SE)<\/span><\/td>\n<\/tr>\n
\u7533\u62a5\u4ea7\u54c1<\/span><\/td>\nAssunto Produto<\/span><\/td>\n<\/tr>\n
\u4e34\u5e8a\u8bd5\u9a8c\u65b9\u6848<\/span><\/td>\nProtocolo de ensaio cl\u00ednico<\/span><\/td>\n<\/tr>\n
\u5c0f\u6837\u672c\u53ef\u884c\u6027\u7814\u7a76<\/span><\/td>\nEstudo de viabilidade de pequenas amostras<\/span><\/td>\n<\/tr>\n
\u4f26\u7406\u59d4\u5458\u4f1a\u610f\u89c1<\/span><\/td>\nPareceres do Comit\u00e9 de \u00c9tica<\/span><\/td>\n<\/tr>\n
\u5b89\u5168\u6027\u8bc4\u4ef7\u65b9\u6cd5<\/span><\/td>\nM\u00e9todo de avalia\u00e7\u00e3o da seguran\u00e7a<\/span><\/td>\n<\/tr>\n
\u6709\u6548\u6027\u8bc4\u4ef7\u65b9\u6cd5<\/span><\/td>\nM\u00e9todo de avalia\u00e7\u00e3o da efic\u00e1cia<\/span><\/td>\n<\/tr>\n
\u4e13\u5bb6\u54a8\u8be2\u4f1a\u8bae<\/span><\/td>\nReuni\u00e3o de consulta de peritos<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u76d1\u7763\u7ba1\u7406\u53f8<\/span><\/td>\nDepartamento de Regulamenta\u00e7\u00e3o dos Dispositivos M\u00e9dicos<\/span><\/td>\n<\/tr>\n
\u4e2d\u56fd\u98df\u54c1\u836f\u54c1\u68c0\u5b9a\u7814\u7a76\u9662<\/span><\/td>\nInstitutos Nacionais de Controlo de Alimentos e Medicamentos<\/span><\/td>\n<\/tr>\n
\u56fd\u5bb6\u836f\u5178\u59d4\u5458\u4f1a<\/span><\/td>\nComiss\u00e3o da Farmacopeia Chinesa<\/span><\/td>\n<\/tr>\n
\u4e2d\u56fd\u98df\u54c1\u836f\u54c1\u56fd\u9645\u4ea4\u6d41\u4e2d\u5fc3<\/span><\/td>\nCentro de Interc\u00e2mbio Internacional de Alimentos e Medicamentos da China<\/span><\/td>\n<\/tr>\n
\u4e2d\u534e\u4eba\u6c11\u5171\u548c\u56fd\u836f\u5178<\/span><\/td>\nFarmacopeia da Rep\u00fablica Popular da China<\/span><\/td>\n<\/tr>\n
\u4e2d\u534e\u4eba\u6c11\u5171\u548c\u56fd\u6807\u51c6\u5316\u6cd5<\/span><\/td>\nLei de Normaliza\u00e7\u00e3o da Rep\u00fablica Popular da China<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u8d28\u91cf\u62bd\u67e5\u68c0\u9a8c\u7ba1\u7406\u529e\u6cd5<\/span><\/td>\nas medidas administrativas para a inspe\u00e7\u00e3o por amostragem da qualidade dos dispositivos m\u00e9dicos<\/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>\nMedidas administrativas para os laborat\u00f3rios principais da NMPA<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u4ea7\u54c1\u51fa\u53e3\u9500\u552e\u8bc1\u660e<\/span><\/td>\nLicen\u00e7a de exporta\u00e7\u00e3o e venda de dispositivos m\u00e9dicos<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u751f\u4ea7\u8bb8\u53ef\u8bc1<\/span><\/td>\nCertificado de fabrico de dispositivos m\u00e9dicos<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u751f\u4ea7\u5907\u6848\u51ed\u8bc1<\/span><\/td>\nCertificado de dep\u00f3sito de fabrico de dispositivos m\u00e9dicos<\/span><\/td>\n<\/tr>\n
\u5185\u90e8\u6838\u67e5<\/span><\/td>\nVerifica\u00e7\u00e3o interna<\/span><\/td>\n<\/tr>\n
\u7f51\u7edc\u6838\u9a8c<\/span><\/td>\nVerifica\u00e7\u00e3o em linha<\/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>\nAn\u00fancio sobre os requisitos para os dossi\u00eas de pedido de registo de dispositivos m\u00e9dicos e o formato dos documentos de aprova\u00e7\u00e3o<\/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>\nAn\u00fancio relativo aos requisitos para os dossi\u00eas de pedido de registo de reagentes para diagn\u00f3stico in vitro e ao formato dos documentos de aprova\u00e7\u00e3o<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u5f3a\u5236\u6027\u884c\u4e1a\u6807\u51c6<\/span><\/td>\nNormas obrigat\u00f3rias da ind\u00fastria para dispositivos m\u00e9dicos<\/span><\/td>\n<\/tr>\n
\u5f3a\u5236\u6027\u884c\u4e1a\u6807\u51c6\u4f53\u7cfb<\/span><\/td>\nSistema de normas obrigat\u00f3rias para o sector<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u5b9a\u671f\u98ce\u9669\u8bc4\u4ef7\u62a5\u544a<\/span><\/td>\nRelat\u00f3rios peri\u00f3dicos de avalia\u00e7\u00e3o do risco de dispositivos m\u00e9dicos<\/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>\nOrienta\u00e7\u00f5es para a inspe\u00e7\u00e3o no local de software independente anexado \u00e0s Boas Pr\u00e1ticas de Fabrico de Dispositivos M\u00e9dicos<\/span><\/td>\n<\/tr>\n
\u9ad8\u503c\u533b\u7528\u8017\u6750<\/span><\/td>\nConsum\u00edveis m\u00e9dicos de elevado valor<\/span><\/td>\n<\/tr>\n
\u96c6\u4e2d\u91c7\u8d2d<\/span><\/td>\nAprovisionamento centralizado<\/span><\/td>\n<\/tr>\n
\u65e0\u83cc\u548c\u690d\u5165\u6027\u533b\u7597\u5668\u68b0\u76d1\u7763\u68c0\u67e5<\/span><\/td>\nSupervis\u00e3o e Inspe\u00e7\u00e3o de Dispositivos M\u00e9dicos Esterilizados e Implant\u00e1veis<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u6ce8\u518c\u4eba<\/span><\/td>\nRegistantes de dispositivos m\u00e9dicos<\/span><\/td>\n<\/tr>\n
\u56fd\u5bb6\u533b\u7597\u5668\u68b0\u4e0d\u826f\u4e8b\u4ef6\u76d1\u6d4b\u4fe1\u606f\u7cfb\u7edf<\/span><\/td>\no Sistema Nacional de Informa\u00e7\u00e3o de Monitoriza\u00e7\u00e3o de Eventos Adversos de Dispositivos M\u00e9dicos<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u4e0d\u826f\u4e8b\u4ef6\u4fe1\u606f\u901a\u62a5<\/span><\/td>\nNotifica\u00e7\u00e3o de Informa\u00e7\u00f5es sobre Eventos Adversos de Dispositivos M\u00e9dicos<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u8b66\u6212\u5feb\u8baf<\/span><\/td>\nExpress\u00f5es sobre Farmacovigil\u00e2ncia de Dispositivos M\u00e9dicos<\/span><\/td>\n<\/tr>\n
\u53ef\u7591\u533b\u7597\u5668\u68b0\u4e0d\u826f\u4e8b\u4ef6\u62a5\u544a<\/span><\/td>\nSuspeitas de acontecimentos adversos com dispositivos m\u00e9dicos<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u62d3\u5c55\u6027\u4e34\u5e8a\u8bd5\u9a8c\u7ba1\u7406\u89c4\u5b9a<\/span><\/td>\nRegulamentos para a Administra\u00e7\u00e3o de Ensaios Cl\u00ednicos Alargados de Dispositivos M\u00e9dicos<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u552f\u4e00\u6807\u8bc6\u6570\u636e\u5e93<\/span><\/td>\nBase de dados de identifica\u00e7\u00e3o \u00fanica de dispositivos m\u00e9dicos<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u901a\u7528\u540d\u79f0\u547d\u540d<\/span><\/td>\nNomenclatura para designa\u00e7\u00f5es comuns de dispositivos m\u00e9dicos<\/span><\/td>\n<\/tr>\n
\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40<\/span><\/td>\nAdministra\u00e7\u00e3o Nacional de Produtos M\u00e9dicos, NMPA<\/span><\/td>\n<\/tr>\n
\u56fd\u5bb6\u536b\u751f\u5065\u5eb7\u59d4<\/span><\/td>\nComiss\u00e3o Nacional de Sa\u00fade NHC<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u6807\u51c6\u7ba1\u7406\u4e2d\u5fc3<\/span><\/td>\nCentro de Gest\u00e3o de Normas para Dispositivos M\u00e9dicos<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u6280\u672f\u5ba1\u8bc4\u4e2d\u5fc3<\/span><\/td>\nCentro de Avalia\u00e7\u00e3o de Dispositivos M\u00e9dicos, CMDE<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u76d1\u7763\u7ba1\u7406\u6761\u4f8b<\/span><\/td>\nRegulamentos para a Supervis\u00e3o e Administra\u00e7\u00e3o de Dispositivos M\u00e9dicos<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u6ce8\u518c\u7ba1\u7406\u529e\u6cd5<\/span><\/td>\nDisposi\u00e7\u00f5es relativas ao registo de dispositivos m\u00e9dicos<\/span><\/td>\n<\/tr>\n
\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u6ce8\u518c\u7ba1\u7406\u529e\u6cd5<\/span><\/td>\nDisposi\u00e7\u00f5es relativas ao registo de reagentes para diagn\u00f3stico in vitro<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u8bf4\u660e\u4e66\u548c\u6807\u7b7e\u7ba1\u7406\u89c4\u5b9a<\/span><\/td>\nDisposi\u00e7\u00f5es relativas \u00e0s instru\u00e7\u00f5es e aos r\u00f3tulos dos dispositivos m\u00e9dicos<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u6807\u51c6\u7ba1\u7406\u529e\u6cd5<\/span><\/td>\nDisposi\u00e7\u00f5es relativas \u00e0s normas para dispositivos m\u00e9dicos<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u5206\u7c7b\u89c4\u5219<\/span><\/td>\nRegras de classifica\u00e7\u00e3o dos dispositivos m\u00e9dicos<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u4e34\u5e8a\u8bd5\u9a8c\u8d28\u91cf\u7ba1\u7406\u89c4\u8303<\/span><\/td>\nBoas Pr\u00e1ticas Cl\u00ednicas para Dispositivos M\u00e9dicos<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303<\/span><\/td>\nBPF para dispositivos m\u00e9dicos<\/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>\nDisposi\u00e7\u00f5es relativas \u00e0 monitoriza\u00e7\u00e3o e reavalia\u00e7\u00e3o dos acontecimentos adversos dos dispositivos m\u00e9dicos<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u8d28\u91cf\u62bd\u67e5\u68c0\u9a8c\u7ba1\u7406\u529e\u6cd5<\/span><\/td>\nMedidas administrativas para a inspe\u00e7\u00e3o por amostragem da qualidade dos dispositivos m\u00e9dicos<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u6ce8\u518c\u4eba\u5236\u5ea6<\/span><\/td>\nSistema de registo de dispositivos m\u00e9dicos<\/span><\/td>\n<\/tr>\n
\u521b\u65b0\u533b\u7597\u5668\u68b0\u7279\u522b\u5ba1\u67e5\u7a0b\u5e8f<\/span><\/td>\nProcedimentos de an\u00e1lise especial de dispositivos m\u00e9dicos inovadores<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u9644\u6761\u4ef6\u6279\u51c6\u4e0a\u5e02<\/span><\/td>\nAprova\u00e7\u00e3o condicional para a comercializa\u00e7\u00e3o de dispositivos m\u00e9dicos<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u4ea7\u54c1\u6ce8\u518c\u9879\u76ee\u7acb\u5377\u5ba1\u67e5<\/span><\/td>\nApresenta\u00e7\u00e3o da revis\u00e3o dos elementos de registo de dispositivos m\u00e9dicos<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u6ce8\u518c\u7535\u5b50\u7533\u62a5\u4fe1\u606f\u5316\u7cfb\u7edf<\/span><\/td>\nsistema eletr\u00f3nico de apresenta\u00e7\u00e3o de produtos regulamentados (eRPS)<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u6ce8\u518c\u7535\u5b50\u7533\u62a5<\/span><\/td>\nAplica\u00e7\u00e3o eletr\u00f3nica do registo de dispositivos m\u00e9dicos<\/span><\/td>\n<\/tr>\n
\u9996\u6b21\u6ce8\u518c<\/span><\/td>\nRegistos iniciais<\/span><\/td>\n<\/tr>\n
\u5ef6\u7eed\u6ce8\u518c<\/span><\/td>\nRenova\u00e7\u00f5es de registo<\/span><\/td>\n<\/tr>\n
\u53d8\u66f4\u6ce8\u518c<\/span><\/td>\nAltera\u00e7\u00f5es de registo<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u68c0\u9a8c\u68c0\u6d4b\u673a\u6784<\/span><\/td>\nOrganiza\u00e7\u00f5es de Inspe\u00e7\u00e3o e Teste de Dispositivos M\u00e9dicos<\/span><\/td>\n<\/tr>\n
\u4e34\u5e8a\u8bd5\u9a8c\u5ba1\u8bc4\u7533\u8bf7<\/span><\/td>\nPedido de an\u00e1lise e aprova\u00e7\u00e3o de ensaios cl\u00ednicos<\/span><\/td>\n<\/tr>\n
\u514d\u4e8e\u8fdb\u884c\u4e34\u5e8a\u8bd5\u9a8c\u533b\u7597\u5668\u68b0\u76ee\u5f55<\/span><\/td>\nCat\u00e1logos de dispositivos m\u00e9dicos isentos de ensaios cl\u00ednicos<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u6ce8\u518c\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u6838\u67e5<\/span><\/td>\nVerifica\u00e7\u00e3o do Sistema de Gest\u00e3o da Qualidade do Registo de Dispositivos M\u00e9dicos<\/span><\/td>\n<\/tr>\n
\u751f\u4ea7\u73b0\u573a\u68c0\u67e5<\/span><\/td>\nInspec\u00e7\u00f5es ao local de produ\u00e7\u00e3o<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u5b89\u5168\u548c\u6027\u80fd\u57fa\u672c\u539f\u7406<\/span><\/td>\nPrinc\u00edpios fundamentais para a seguran\u00e7a e o desempenho dos dispositivos m\u00e9dicos<\/span><\/td>\n<\/tr>\n
\u7533\u62a5\u8d44\u6599<\/span><\/td>\nDossi\u00eas de candidatura<\/span><\/td>\n<\/tr>\n
\u6ce8\u518c\u5ba1\u8bc4\u5ba1\u6279<\/span><\/td>\nRevis\u00e3o e aprova\u00e7\u00e3o do registo<\/span><\/td>\n<\/tr>\n
\u56fd\u5bb6\u533b\u7597\u5668\u68b0\u4e0d\u826f\u4e8b\u4ef6\u76d1\u6d4b\u5e74\u5ea6\u62a5\u544a<\/span><\/td>\nRelat\u00f3rio Anual sobre a Monitoriza\u00e7\u00e3o Nacional dos Eventos Adversos dos Dispositivos M\u00e9dicos<\/span><\/td>\n<\/tr>\n
\u56fd\u4ea7\u5668\u68b0<\/span><\/td>\nDispositivo dom\u00e9stico<\/span><\/td>\n<\/tr>\n
\u8fdb\u53e3\u5668\u68b0<\/span><\/td>\nDispositivo importado<\/span><\/td>\n<\/tr>\n
\u5916\u6e90\u56e0\u5b50<\/span><\/td>\nAgentes advent\u00edcios<\/span><\/td>\n<\/tr>\n
\u9633\u6027\u5bf9\u7167\u8bd5\u9a8c<\/span><\/td>\nEnsaios controlados activos<\/span><\/td>\n<\/tr>\n
\u7533\u8bf7\u4eba<\/span><\/td>\nRequerente<\/span><\/td>\n<\/tr>\n
\u7b80\u8981\u603b\u7ed3<\/span><\/td>\nBreve resumo<\/span><\/td>\n<\/tr>\n
\u83b7\u76ca\u4e0e\u98ce\u9669\u7ed3\u8bba<\/span><\/td>\nConclus\u00f5es sobre benef\u00edcios e riscos<\/span><\/td>\n<\/tr>\n
\u751f\u7269\u836f\u5242\u5b66\u7814\u7a76<\/span><\/td>\nEstudos biofarmac\u00eauticos<\/span><\/td>\n<\/tr>\n
\u751f\u7269\u5229\u7528\u5ea6<\/span><\/td>\nBiodisponibilidade<\/span><\/td>\n<\/tr>\n
\u751f\u7269\u7b49\u6548\u6027<\/span><\/td>\nBioequival\u00eancia<\/span><\/td>\n<\/tr>\n
\u4e34\u5e8a\u7efc\u8ff0<\/span><\/td>\nPanorama cl\u00ednico<\/span><\/td>\n<\/tr>\n
\u4e34\u5e8a\u603b\u7ed3<\/span><\/td>\nResumo cl\u00ednico<\/span><\/td>\n<\/tr>\n
\u4e34\u5e8a\u7814\u7a76\u62a5\u544a<\/span><\/td>\nRelat\u00f3rios de estudos cl\u00ednicos<\/span><\/td>\n<\/tr>\n
\u4e34\u5e8a\u6709\u6548\u6027<\/span><\/td>\nEfic\u00e1cia cl\u00ednica<\/span><\/td>\n<\/tr>\n
\u4e34\u5e8a\u5b89\u5168\u6027<\/span><\/td>\nSeguran\u00e7a cl\u00ednica<\/span><\/td>\n<\/tr>\n
\u4e34\u5e8a\u836f\u7406\u5b66<\/span><\/td>\nFarmacologia cl\u00ednica<\/span><\/td>\n<\/tr>\n
\u63a7\u5236\u7b56\u7565<\/span><\/td>\nEstrat\u00e9gia de controlo<\/span><\/td>\n<\/tr>\n
\u836f\u5178\u5404\u8bba<\/span><\/td>\nMonografias de comp\u00eandio<\/span><\/td>\n<\/tr>\n
\u5173\u952e\u6b65\u9aa4<\/span><\/td>\nEtapas cr\u00edticas<\/span><\/td>\n<\/tr>\n
\u836f\u5178<\/span><\/td>\nComp\u00eandio<\/span><\/td>\n<\/tr>\n
\u5bf9\u7167\u4e34\u5e8a\u8bd5\u9a8c<\/span><\/td>\nEnsaios cl\u00ednicos controlados<\/span><\/td>\n<\/tr>\n
\u7269\u6599\u63a7\u5236<\/span><\/td>\nControlo dos materiais<\/span><\/td>\n<\/tr>\n
\u901a\u7528\u6280\u672f\u6587\u6863<\/span><\/td>\nDocumento t\u00e9cnico comum<\/span><\/td>\n<\/tr>\n
\u6d53\u5ea6<\/span><\/td>\nConcentra\u00e7\u00e3o<\/span><\/td>\n<\/tr>\n
\u5305\u88c5\u7cfb\u7edf<\/span><\/td>\nSistema de fecho de contentores<\/span><\/td>\n<\/tr>\n
\u5236\u5242<\/span><\/td>\nMedicamento<\/span><\/td>\n<\/tr>\n
\u53cc\u76f2\u3001\u9633\u6027\u5bf9\u7167\u8bd5\u9a8c<\/span><\/td>\nEnsaio duplo cego, ativo e controlado<\/span><\/td>\n<\/tr>\n
\u539f\u6599\u836f\/\u539f\u6db2<\/span><\/td>\nSubst\u00e2ncia medicamentosa<\/span><\/td>\n<\/tr>\n
\u5242\u578b<\/span><\/td>\nForma de dosagem<\/span><\/td>\n<\/tr>\n
\u53cc\u76f2\u3001\u5b89\u6170\u5242\u5bf9\u7167\u8bd5\u9a8c<\/span><\/td>\nEnsaio duplo cego, controlado por placebo<\/span><\/td>\n<\/tr>\n
\u8bbe\u5907<\/span><\/td>\nEquipamento<\/span><\/td>\n<\/tr>\n
\u8f85\u6599<\/span><\/td>\nExcipiente<\/span><\/td>\n<\/tr>\n
\u6709\u6548\u6027<\/span><\/td>\nEfic\u00e1cia<\/span><\/td>\n<\/tr>\n
\u8bbe\u65bd<\/span><\/td>\nInstala\u00e7\u00f5es<\/span><\/td>\n<\/tr>\n
\u7ed3\u679c<\/span><\/td>\nConclus\u00f5es<\/span><\/td>\n<\/tr>\n
\u6307\u5357<\/span><\/td>\nOrienta\u00e7\u00e3o<\/span><\/td>\n<\/tr>\n
\u7c92\u5ea6\u6587\u4ef6<\/span><\/td>\nDocumento de granularidade<\/span><\/td>\n<\/tr>\n
\u57fa\u672c\u4fe1\u606f<\/span><\/td>\nInforma\u00e7\u00f5es gerais<\/span><\/td>\n<\/tr>\n
\u901a\u7528\u672f\u8bed\u8868<\/span><\/td>\nGloss\u00e1rio geral de termos<\/span><\/td>\n<\/tr>\n
\u4e00\u822c\u539f\u5219<\/span><\/td>\nPrinc\u00edpios gerais<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>","protected":false},"excerpt":{"rendered":"

Chin\u00eas Ingl\u00eas \u4ea7\u54c1\u6280\u672f\u8d44\u6599 Materiais T\u00e9cnicos do Produto \u68c0\u9a8c\u4e2d\u5fc3 Centro de Testes \u6ce8\u518c\u68c0\u9a8c Teste de Registo \u6ce8\u518c\u5355\u5143 Unidade Registada \u9884\u8bc4\u4ef7\u610f\u89c1 Pareceres de Pr\u00e9-avalia\u00e7\u00e3o \u540c\u54c1\u79cd\u533b\u7597\u5668\u68b0 Dispositivo M\u00e9dico Predicado \u4e34\u5e8a\u8bd5\u9a8c\u673a\u6784 Institutos de Ensaios Cl\u00ednicos \u4f26\u7406\u59d4\u5458\u4f1a Comit\u00e9 de \u00c9tica \u591a\u4e2d\u5fc3\u4e34\u5e8a\u8bd5\u9a8c Ensaios Cl\u00ednicos Multic\u00eantricos \u5f62\u5f0f\u5ba1\u67e5 Exame Formal \u8ba4\u8bc1\u8bc1\u4e66 Autoridade de Certifica\u00e7\u00e3o, CA \u53d7\u7406\u901a\u77e5\u5355 Aviso de aceita\u00e7\u00e3o \u7f34\u8d39\u901a\u77e5\u4e66 Fatura de pagamento \u8865\u6b63\u8d44\u6599\u901a\u77e5\u4e66 Carta de defici\u00eancia \u4e0d\u4e88\u53d7\u7406\u901a\u77e5\u4e66 Aviso de rejei\u00e7\u00e3o \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\/pt\/wp-json\/wp\/v2\/posts\/769"}],"collection":[{"href":"https:\/\/www.consulting-hmk.com\/pt\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.consulting-hmk.com\/pt\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.consulting-hmk.com\/pt\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/www.consulting-hmk.com\/pt\/wp-json\/wp\/v2\/comments?post=769"}],"version-history":[{"count":0,"href":"https:\/\/www.consulting-hmk.com\/pt\/wp-json\/wp\/v2\/posts\/769\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.consulting-hmk.com\/pt\/wp-json\/wp\/v2\/media\/770"}],"wp:attachment":[{"href":"https:\/\/www.consulting-hmk.com\/pt\/wp-json\/wp\/v2\/media?parent=769"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.consulting-hmk.com\/pt\/wp-json\/wp\/v2\/categories?post=769"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.consulting-hmk.com\/pt\/wp-json\/wp\/v2\/tags?post=769"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}