Labelling Requirements
This page provides a plain English reference for labelling requirements under China's NMPA regulatory framework. Full content to be completed during editorial review.
Regulatory basis
- MDSAR 2021 (State Council Order No. 739)
- Adverse Event Monitoring & Re-evaluation Measures
- Relevant NMPA orders and announcements
Key requirements
Labelling requirements are set out in MDSAR 2021 Articles 59-62 and the Technical Guidance for Medical Device Labelling. See Legislation & Regulations for the full legislative index.
- 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.
Medical device labelling in China must comply with MDSAR 2021 Articles 59-62 and the Technical Guidance for Medical Device Labelling. Key requirements include: primary language is Mandarin Chinese (simplified characters); English may appear alongside but not as primary; essential information includes: device name (registered name), intended use, contraindications, warnings and precautions, directions for use, storage conditions, shelf life, manufacturer/distributor information, registration certificate number, and unique device identification (UDI). For imported devices, Chinese translations must be accurate and complete. Class III devices require more detailed labelling. NMPA publishes labelling templates and examples on the medical device registration portal.