Investigation Group of Technical Guideline of Hemostasis Diagnostic Reagent Products Registration were Presented and Gave Instructions to Our Company

On 28th October, 2020, according to the requirement of National Medical Products Administration Medical Apparatus and Instruments Technical Evaluation Centre, Zhejiang Medical Products Administration Medical Apparatus and Instruments Technical Evaluation Centre took the lead to organize Shanghai Medical Products Administration Accessment Centre and Shandong Medical Products Accessment Centre as a prothrombin time, activated partial thromboplastin time, thrombin time and fibrinogen reagent products registration technical guideline investigation group.

The group discussed the first draft of guideline and communicated about many aspects, such as the production flow, quality control, performance evaluation, quality management etc, through colloquia. Also, they had in-depth understanding of our products production and quality control process by visiting the diagnostic reagent production workshop.