Common Problems and Suggestions on Full Life-cycle Supervision and Administration of Diagnostics / 中国医疗器械杂志
Chinese Journal of Medical Instrumentation
;
(6): 129-132, 2018.
Artigo
em Chinês
| WPRIM
| ID: wpr-774491
ABSTRACT
This article analyzes common problems and offers some suggestions on full life-cycle supervision and administration process of diagnostics, including premarket technical evaluations, pre-market QMS on-site inspections, postmarket adverse event surveillance, unannounced inspections and re-evaluation, from regulators' perspectives. It aims to provide technical reference for revisions on regulations, and help government administrators to figure out major points in daily regulatory practice.
Texto completo:
DisponíveL
Índice:
WPRIM (Pacífico Ocidental)
Assunto principal:
Vigilância de Produtos Comercializados
/
Diagnóstico
/
Equipamentos e Provisões
Tipo de estudo:
Estudo diagnóstico
Idioma:
Chinês
Revista:
Chinese Journal of Medical Instrumentation
Ano de publicação:
2018
Tipo de documento:
Artigo
Similares
MEDLINE
...
LILACS
LIS