Reflections on the Key Points in the Establishment of the Guidelines for Class II Medical Device Technical Review-Example of Intraoral Digital Dental Impression / 中国医疗器械杂志
Chinese Journal of Medical Instrumentation
;
(6): 425-429, 2020.
Artigo
em Chinês
| WPRIM
| ID: wpr-942754
ABSTRACT
Technical Review Guidelines of Medical Devices are standards to standardize and unify registration review of medical devices marketed in China. The writing quality of the guidelines affects not only the time for technical evaluation, but also the safety and effectiveness of approved products. Based on authors' practices of nearly 30 class II medical equipment technical guidelines written and 20-year experience in class II medical device evaluation, this study takes intraoral digital dental impressions as an example to put forward several key points of sections "summary" and "research data" in the guidelines, for researchers on class II medical equipment technical guidelines reference.
Texto completo:
DisponíveL
Índice:
WPRIM (Pacífico Ocidental)
Assunto principal:
China
/
Desenho Assistido por Computador
/
Transferência de Tecnologia
/
Imageamento Tridimensional
Tipo de estudo:
Guia de Prática Clínica
País/Região como assunto:
Ásia
Idioma:
Chinês
Revista:
Chinese Journal of Medical Instrumentation
Ano de publicação:
2020
Tipo de documento:
Artigo
Similares
MEDLINE
...
LILACS
LIS