Single-Use Devices
This page provides a plain English reference for single-use devices requirements under China's NMPA regulatory framework. Full content to be completed during editorial review.
Regulatory basis
Requirements for single-use devices are set out in:
- MDSAR 2021 (State Council Order No. 739)
- Relevant NMPA technical guidelines published on www.cmde.org.cn
- Applicable YY/T and GB standards
Classification implications
Device type significantly affects classification. Consult the National Medical Device Classification Catalogue (NMDCC) for the applicable class for your specific product.
Key obligations
Refer to CMDE technical review guidelines available on www.cmde.org.cn for the latest dossier requirements, including labeling specifications, material compatibility documentation, and reprocessing validation (if applicable) specific to single-use devices.
- NMPA — www.nmpa.gov.cn
- CMDE — www.cmde.org.cn
- NMPA Medical Device Registration Query — datasearch.nmpa.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.
Single-Use Device Requirements: NMPA-approved single-use devices (SUDs) are labeled for one use only and must not be reprocessed or reused. Manufacturers must provide clear, conspicuous labeling stating "Single Use Only" in English and the Chinese equivalent "单次使用" (dāncì shǐyòng) on the device and packaging. If a manufacturer seeks to allow reprocessing and reuse, validation data must be submitted demonstrating safety and effectiveness after reprocessing cycles, and the device classification may be changed accordingly. Required documentation includes: material degradation analysis, sterilization efficacy data after simulated reuse, functional performance testing, bioburden/endotoxin levels, and shelf-life stability post-reprocessing.