Clinical Evaluation Guidance
This page provides an index and plain English summary of clinical evaluation guidance published by NMPA and CMDE. Full content to be completed during editorial review.
Finding official guidance
NMPA technical guidance documents are published on:
- CMDE website: www.cmde.org.cn → 指导原则 (Technical Review Guidelines)
- NMPA website: www.nmpa.gov.cn → 医疗器械 → 法规文件
Content on this site is written with AI assistance and is intended as a navigation aid only. Always verify against official NMPA sources before making regulatory decisions. Not affiliated with NMPA or any Chinese Government body. Not legal or regulatory advice.
NMPA's clinical evaluation guidance requires different evidence strategies based on device risk class and type. For AI and machine learning-based devices, the 2022 AI Medical Device Registration Review Guidance Principle (人工智能医疗器械注册审查指导原则) provides specialized requirements including algorithm performance assessment and real-world validation. Key guidance documents address: clinical study design and endpoints, use of real-world evidence, assessment of algorithm performance, biocompatibility testing, and leveraging existing clinical data. This index will summarize available NMPA clinical evaluation guidance documents with plain English explanations and links to original sources.