27項醫療器械國標、行標正在征求意見(2016.9.19)
日前，全國醫用臨床檢驗實驗室和體外診斷系統標準化技術委員會(SAC/TC136)秘書處發布了“關于《醫學實驗室質量和能力的要求 第2部分：臨床血液學專業的要求》等27項國家標準、行業標準征求意見的通知”。
具體涉及歸口SAC/TC136的7項國家標準、19項行業標準項目和1項在用醫療器械技術要求。
以下為27個具體標準項目：
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Medical device registration
Develop the most convenient, accurate and efficient registration solution, and provide customers with convenient registration services based on the actual situation of the product
IVD registration
Proficient in the registration of various IVD products and understand multi-domain IVD products. Effectively anticipate and circumvent registration risks for clients
Clinical trial
Clinical trial cooperation organizations throughout the country, excellent team service, fast and efficient data statistics and report writing
Clinical evaluation
Clinical trial cooperation organizations throughout the country, excellent team service, fast and efficient data statistics and report writing clinical trial cooperation organizations throughout the country, excellent team service, fast and efficient data statistics and report writing
Cosmetics registration
Clinical trial cooperation organizations throughout the country, excellent team services, fast and efficient data statistics and report writing are well versed in the registration of various IVD products, and understand multi-disciplinary IVD products. Effectively anticipate and circumvent registration risks for clients