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Radiation-Emitting Devices

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

Regulatory basis​

Requirements for radiation-emitting 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 specific to this device type for the latest dossier requirements.

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.

Radiation-emitting devices require additional safety and performance testing beyond standard device requirements. Dossiers must include: radiation safety documentation per applicable standards (GB 5566 for diagnostic X-ray, GB 11318 for laser devices, etc.); shielding design and validation; dose rate measurement data; radiation output consistency testing; and quality control procedures. Coordination with China's Ministry of Ecology and Environment (radiation safety licensing) and National Health Commission may be required. Some radiation devices require pre-approval radiation safety inspection. Annual quality control and periodic safety inspections are post-market obligations.