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.
Article
en Zh
| WPRIM
| ID: wpr-942754
Biblioteca responsable:
WPRO
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.
Palabras clave
Texto completo:
1
Base de datos:
WPRIM
Asunto principal:
China
/
Diseño Asistido por Computadora
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Transferencia de Tecnología
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Imagenología Tridimensional
Tipo de estudio:
Guideline
País/Región como asunto:
Asia
Idioma:
Zh
Revista:
Chinese Journal of Medical Instrumentation
Año:
2020
Tipo del documento:
Article