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Clinical Trial Requirements

Clinical trials for medical devices in China are governed by the Administrative Measures for Clinical Trials of Medical Devices (医疗器械临床试验质量管理规范) and associated NMPA guidance.

Pre-trial NMPA approval​

For Class III devices, the sponsor must submit a clinical trial application to NMPA and obtain approval before commencing the trial. NMPA has 60 working days to review. If NMPA does not object within the review period, the trial may commence (implied approval).

For Class II devices, NMPA approval is not required before commencing, but ethics committee approval and trial registration are mandatory.

Clinical trial institutions​

Trials must be conducted at institutions that have completed qualification filing (备案) with NMPA as clinical trial institutions. A list of qualified institutions is published on the NMPA website. Class III trials typically require a minimum of 3 institutions; Class II typically requires 2 institutions.

GCP requirements​

Trials must comply with the Good Clinical Practice for Medical Device Clinical Trials (医疗器械临床试验质量管理规范):

  • Ethics committee: approval required at each participating institution before enrolment begins
  • Informed consent: written consent required from each participant
  • Principal investigator: qualified physician with relevant expertise
  • Sponsor responsibilities: protocol development, monitoring, adverse event reporting, data management
  • CRO: clinical research organisations may be engaged by the sponsor but do not transfer sponsor liability

Trial registration​

All clinical trials must be registered in the China Clinical Trial Registry (中国临床试验注册中心 — ChiCTR) before the first participant is enrolled. The registration number must be included in the registration dossier.

Trial data submission​

The full clinical trial report (临床试验报告) must be submitted as part of the registration dossier. CMDE evaluates the statistical methodology, endpoint selection, clinical relevance of results, and adverse event data.

Disclaimer

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.