SOURCE RECORD / S0188
医疗器械临床评价技术指导原则等5项技术指导原则通告（2021年第73号）
医疗器械临床评价技术指导原则等5项技术指导原则通告（2021年第73号）
- Authors or organization
- 国家药品监督管理局
- Published date
- 2021-09-28
- Source type
- regulatory_guidance_notice
- Technology route
- medical devices
- Function or setting
- clinical evaluation
- Rights status
- manual_review
Evidence summary
Evidence: Clinical evaluation principles and routes using equivalent-device data or clinical trials. Key figures: 2021年第73号通告; 5 guidance documents. Limitations: Does not classify BCI or grant exemption from clinical trials; NMPA automated access returned 412; government mirror used for title and date.
Key figures
2021年第73号通告; 5 guidance documents
Limitations
Does not classify BCI or grant exemption from clinical trials; NMPA automated access returned 412; government mirror used for title and date