SOURCE RECORD / S0170
医疗器械软件注册审查指导原则（2022年修订版）
医疗器械软件注册审查指导原则（2022年修订版）
- Authors or organization
- 国家药品监督管理局医疗器械技术审评中心
- Published date
- 2022-03-09
- Source type
- regulatory_guidance
- Technology route
- medical software
- Function or setting
- software lifecycle and registration
- Rights status
- manual_review
Evidence summary
Evidence: Software lifecycle and registration materials. Key figures: one of 9 guidance documents in announcement. Limitations: NMPA automated access returned 412; title cross-checked via official URL and public mirror; guidance is not product approval.
Key figures
one of 9 guidance documents in announcement
Limitations
NMPA automated access returned 412; title cross-checked via official URL and public mirror; guidance is not product approval