Discussion on Technical Evaluation Requirements of Allergen Detection Reagent Pre-marketing / 中国医疗器械杂志
Chinese Journal of Medical Instrumentation
; (6): 318-322, 2022.
Article
en Zh
| WPRIM
| ID: wpr-928912
Biblioteca responsable:
WPRO
ABSTRACT
In the perspective of technical evaluation, the pre-marketing regulatory requirements of allergen detection reagents in China, America, European Union were compared, and the regulatory risks and performance requirements of this product were analyzed based on the monitoring of post-marketing adverse events, reference standards and domestic and foreign regulatory documents. In view of the "neck-stuck" problems such as the difficulty of clinical trials, the difficulty of finding comparable contrast reagents and the lack of clinical diagnostic gold standards, this paper discusses and gives regulatory suggestions, with a view to providing technical reference for product R&D, production, evaluation, approval and supervision in this field.
Palabras clave
Texto completo:
1
Índice:
WPRIM
Asunto principal:
Estándares de Referencia
/
Alérgenos
/
Mercadotecnía
/
Unión Europea
/
Indicadores y Reactivos
Tipo de estudio:
Diagnostic_studies
/
Guideline
Idioma:
Zh
Revista:
Chinese Journal of Medical Instrumentation
Año:
2022
Tipo del documento:
Article