SOURCE RECORD / S0189
医疗器械临床试验质量管理规范（2022年第28号公告）
医疗器械临床试验质量管理规范（2022年第28号公告）
- Authors or organization
- 国家药品监督管理局和国家卫生健康委员会
- Published date
- 2022-03-31
- Source type
- regulatory_rule
- Technology route
- medical devices
- Function or setting
- clinical trial GCP
- Rights status
- manual_review
Legacy aliases
—
Related topics
- BCI 最优方案
- 中国监管与标准
Evidence summary
Evidence: Current medical-device clinical-trial GCP. Key figures: 2022年第28号公告; effective 2022-05-01. Limitations: Applies when a device clinical trial is required; cannot imply every BCI must undergo a trial; NMPA 412 cross-checked via provincial forwarding page.
Key figures
2022年第28号公告; effective 2022-05-01
Limitations
Applies when a device clinical trial is required; cannot imply every BCI must undergo a trial; NMPA 412 cross-checked via provincial forwarding page
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