SOURCE RECORD / S0190
创新医疗器械特别审查程序（2018年第83号公告）
创新医疗器械特别审查程序（2018年第83号公告）
- Authors or organization
- 国家药品监督管理局
- Published date
- 2018-11-05
- Source type
- regulatory_procedure
- Technology route
- medical devices
- Function or setting
- special review
- Rights status
- manual_review
Evidence summary
Evidence: Application and review boundary for innovative-device special review. Key figures: 2018年第83号公告. Limitations: Inclusion requires application and review; it is not automatic for BCI and is not approval or exemption from safety effectiveness evidence; NMPA 412 cross-checked via government mirror.
Key figures
2018年第83号公告
Limitations
Inclusion requires application and review; it is not automatic for BCI and is not approval or exemption from safety effectiveness evidence; NMPA 412 cross-checked via government mirror