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Clinical Evaluation Overview

Clinical evaluation (临床评价) is required for most Class II and Class III medical device registrations in China. The objective is to demonstrate that the device achieves its intended clinical benefit while the risks are acceptable in the target population.

Three pathways​

NMPA recognises three approaches to generating clinical evidence:

1. Clinical trial (临床试验)​

A prospective study conducted at NMPA-recognised clinical trial institutions (临床试验机构) in China. Required for most Class III devices and some Class II devices not meeting equivalence or exemption criteria.

Key requirements:

  • Sponsor must obtain NMPA approval before commencing the trial (for Class III)
  • Trial must be conducted under GCP (Good Clinical Practice — 医疗器械临床试验质量管理规范)
  • Ethics committee approval required at each site
  • Trial registration in the China Clinical Trial Registry (www.chictr.org.cn)

See Clinical Trial Requirements.

2. Literature and equivalent device (同品种临床评价)​

The manufacturer demonstrates that the device is equivalent to one or more already-registered devices (同品种医疗器械), using published literature and post-market data from those devices.

Equivalence must be demonstrated across:

  • Technical characteristics (materials, dimensions, energy output)
  • Biological characteristics (biocompatibility)
  • Clinical characteristics (intended use, target population, anatomical site)

Access to clinical data of the predicate device is required where the applicant does not own the data. NMPA guidance specifies acceptable evidence levels.

3. Clinical trial exemption (豁免临床试验)​

NMPA publishes a list of device categories exempt from clinical trials. For exempt devices, clinical evidence from the literature or post-market data may be sufficient without a formal clinical trial.

See Clinical Trial Exemption.

Which pathway applies?​

CMDE technical review guidelines for each device type specify the accepted pathways. NMPA CMDE guidance should always be checked before deciding on a clinical strategy.

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.