医疗器械

医疗器械是指直接或者间接用于人体的仪器、设备、器具、体外诊断试剂及校准物、材料以及其他类似或者相关的物品,包括所需要的计算机软件。医疗器械包括医疗设备和医用耗材。 效用主要通过物理等方式获得,不是通过... View details>

1248 discussions,7 Days New 2 discussions,30 Days New 4 discussions

一、适用范围本指导原则适用于第二类、第三类医疗器械可用性工程的注册申报,不适用于体外诊断试剂。二、主要概念(一)可用性工程和可用性可用性工程是指综合运用关于人类的解剖、生理、心理、行为、文化等方面能力与限制的知识来设计开发医疗器械,以增强医...
si4520si4520 Answered the question 2024-04-03 16:31
su1314520su1314520 Answered the question 2024-03-06 22:51
su1314520su1314520 Answered the question 2024-03-05 08:39
su1314520su1314520 Answered the question 2024-03-05 08:36
ss13145ss13145 Answered the question 2024-02-05 13:31
ss13145ss13145 Answered the question 2024-02-05 13:29
ss13145ss13145 Answered the question 2024-02-05 13:28
ss13145ss13145 Answered the question 2024-02-05 13:26
sk6578sk6578 Answered the question 2024-01-30 16:26
sk6578sk6578 Answered the question 2024-01-30 16:26
sk6578sk6578 Answered the question 2024-01-30 16:24
sk6578sk6578 Answered the question 2024-01-30 16:23
cyxwvoarncyxwvoarn Answered the question 2024-01-30 16:22
sk6578sk6578 Answered the question 2024-01-30 16:21

22 People pay attention to this topic

hot topic

审计认证

生物相容性

FDA

PLC

仓储物流