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Active (Powered) Devices

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

Regulatory basis​

Requirements for active (powered) 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.

For active devices, key dossier elements include: electrical safety testing per GB 9706 series and applicable IEC standards; biocompatibility assessment per ISO 10993 (relevant parts determined by duration and contact type); software validation documentation; electromagnetic compatibility (EMC) testing per GB 4343; and performance testing demonstrating intended functionality. Sterile active devices must additionally include sterilization validation and shelf-life stability data. Refer to specific CMDE technical guidelines for your device category.