SOURCE RECORD / S0171
Medical Device Cybersecurity Registration Review Guidance (2022 revision)
Medical Device Cybersecurity 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 device cybersecurity
- Function or setting
- cybersecurity registration
- Rights status
- manual_review
Legacy aliases
3DB-S041 · CLM-S051
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: Cybersecurity lifecycle, major-update, patch-validation, and medical-data localization controls. Key figures: Announcement No. 7 of 2022; official DOCX SHA-256 0c86ba0c14cdd4451441749b9b482801bb256458c516651920be48d1c70fc536. Limitations: Cross-border duties remain scenario-specific; full-document redistribution rights were not verified.
Key figures
2022年第7号; official DOCX SHA-256 0c86ba0c14cdd4451441749b9b482801bb256458c516651920be48d1c70fc536
Limitations
Guidance is not product approval; cross-border duties remain scenario-specific; redistribution rights for the complete DOCX were not verified
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