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Sterile Devices

This page provides a plain English reference for sterile devices requirements under China's NMPA regulatory framework. Full content to be completed during editorial review.

Regulatory basis​

Requirements for sterile 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 sterilization validation protocols, packaging barrier integrity testing, bioburden/endotoxin data, and shelf-life validation specific to sterile devices.

Official Sources
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.

Sterile Device Requirements: Sterile devices must be sterilized using validated methods (steam sterilization, ethylene oxide, radiation, or other approved methods) and packaged to maintain sterility. Documentation must include: sterilization validation studies (ISO 11135, ISO 11137, or equivalent), bioburden and endotoxin testing, sterility assurance level (SAL) achievement data, and shelf-life validation under defined storage conditions. Packaging materials must demonstrate barrier integrity and compatibility with the sterilization method. All documentation must follow MDSAR 2021 and applicable YY/T standards.