Administrative Measures for Clinical Trials
This page provides a plain English reference for administrative measures for clinical trials in China's medical device regulatory framework. Full content to be completed during editorial review.
Overview
See MDSAR 2021 for the primary regulation. This page covers the implementing measure or standard listed above, explaining its scope, key requirements, and relationship to MDSAR 2021.
Official source
Official texts are published on www.nmpa.gov.cn and the State Council website at www.gov.cn.
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.
Scope
This measure establishes administrative procedures for clinical trials of medical devices in China, covering trial design, ethics review, informed consent, and data management.
Key Requirements
- Clinical trials require prior approval from Ethics Committee (伦理委员会) and NMPA (for Class III devices)
- Informed consent forms must be provided in Chinese and approved by Ethics Committee
- Qualified clinical trial sites and investigators required
- Regular safety monitoring and reporting to Ethics Committee and NMPA
- Trial protocols must comply with GCP (Good Clinical Practice) standards
- Data integrity and traceability requirements throughout trial duration
Relationship to MDSAR 2021
This measure implements registration requirements under Chapter II of MDSAR 2021, particularly Articles 15 and 16, which require clinical data for Class III device registration.