SOURCE RECORD / S0170
Medical Device Software Registration Review Guidance (2022 revision)
Medical Device Software Registration Review Guidance (2022 revision)
- 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
Legacy aliases
3DB-S040 · CLM-S050
Related topics
- 3D 大脑
- BCI 最优方案
- 中国监管与标准
- NMPA 合规实现
- 非侵入合规方案
Evidence summary
Evidence: Software lifecycle, registration-unit, versioning, and major-update controls. Key figures: Announcement No. 9 of 2022; official DOCX SHA-256 4526e98203bb0bd11771b1ea24d84d0d887191dc5463e16bd2d8708dff97943a. Limitations: Guidance is not product approval; full-document redistribution rights were not verified.
Key figures
2022年第9号; official DOCX SHA-256 4526e98203bb0bd11771b1ea24d84d0d887191dc5463e16bd2d8708dff97943a
Limitations
Guidance is not product approval; redistribution rights for the complete DOCX were not verified
This source currently has a local metadata record only. No public mirror is provided because redistribution permission has not been confirmed; use the original source above for verification.