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Clinical Trial Exemption (豁免临床试验)

China-unique

NMPA publishes a formal clinical trial exemption list (免于临床试验医疗器械目录) — a specific administrative list of product categories for which clinical trial evidence is not required. This formal published list is a distinctive feature of the Chinese system; other frameworks (e.g. EU MDR, FDA) have equivalence or literature pathways but no equivalent published categorical exemption list.

What the exemption list covers​

NMPA periodically publishes and updates the exemption list. It includes product categories where clinical evidence from literature, post-market data from equivalent already-registered devices, or bench testing is considered sufficient to demonstrate clinical safety and performance.

Typical exempt categories include:

  • Low-risk reusable surgical instruments
  • Standard wound care products
  • Passive (non-powered) Class I and II devices with well-established clinical use
  • Devices that are structurally and functionally identical to well-established predicate devices

How to use the exemption​

  1. Confirm your device category is on the current NMPA exemption list
  2. In the registration dossier, reference the relevant entry in the exemption list
  3. Provide alternative clinical evidence as required by NMPA guidance for that category — typically literature review and/or post-market data from equivalent devices
  4. CMDE will assess whether the claimed exemption is justified

Important limitations​

  • The exemption list is updated periodically. Always use the current version published on the NMPA/CMDE website.
  • Exemption from clinical trial does not mean exemption from clinical evidence. Literature and post-market data are still required.
  • Novel technology, new intended uses, or novel materials may disqualify a device from exemption even if the general product category is listed.

Official source​

Current NMPA clinical trial exemption list: published on www.nmpa.gov.cn and www.cmde.org.cn.

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.