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1.
Chinese Journal of Medical Instrumentation ; (6): 80-82, 2023.
Artículo en Chino | WPRIM | ID: wpr-971308

RESUMEN

Based on the current situation of approval and publicity of class II innovative medical devices in various provinces and cities, especially after analyzing the problems found in the review of class II innovative medical devices in Shanghai and the factors affecting the listing process of innovative medical devices, this study puts forward some thoughts on supervision for reference in establishing and perfecting systems and regulations, changing the review and approval thinking, extending services to the development of innovative medical devices and the formulation of clinical trial schemes.


Asunto(s)
Aprobación de Recursos , China , Equipos y Suministros
2.
Chinese Journal of Medical Instrumentation ; (6): 258-262, 2020.
Artículo en Chino | WPRIM | ID: wpr-942739

RESUMEN

Wireless technology has been widely used in medical devices and has brought convenience to medical care. However, wireless medical devices face risks such as data security and radio frequency interference. This study highlights safety and effectiveness evaluation of wireless medical devices, and discusses technical characteristics and regulation requirements, providing references for industry development and regulation.


Asunto(s)
Seguridad Computacional , Tecnología Inalámbrica
3.
Chinese Journal of Medical Instrumentation ; (6): 375-377, 2018.
Artículo en Chino | WPRIM | ID: wpr-689783

RESUMEN

The article collected 250 renew registration of domestic Class Ⅱ passive medical devices from Jan. 2016 to Aug. 2017 in Shanghai. It summarized the common problems listed in the correction notifications of the technical evaluation, and then provides some relevant countermeasures or suggestions. So that we can further speed up the evaluation and approval of medical devices.

4.
Chinese Journal of Medical Instrumentation ; (6): 213-217, 2013.
Artículo en Chino | WPRIM | ID: wpr-264231

RESUMEN

Recent years, the development of medical devices kits is rapid. How to make the technical evaluation of medical devices kits more perfect bases on the two major principles of safe and effective, and to make kits in the market more normative and orderly, these issues for technical evaluation have to be considered. This article makes a study on current situation of production, classification of management and registration status, combined with existing regulations and related standards, and discusses technical evaluation related issues.


Asunto(s)
Equipos y Suministros , Estándares de Referencia
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