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YY/T 0287 and ISO 13485

This page provides a plain English reference for yy/t 0287 and iso 13485 under China's NMPA regulatory framework. Full content to be completed during editorial review.

Regulatory basis​

  • MDSAR 2021 (State Council Order No. 739)
  • Medical Device Production Supervision and Administration Measures (NMPA Order No. 53)
  • YY/T 0287-2017 (equivalent to ISO 13485:2016)

Key requirements​

See NMPA GMP guidance for and the YY/T 0287-2017 standard text detailed Ensure your QMS documentation explicitly addresses NMPA-specific requirements including adverse event reporting and Chinese labeling compliance in addition to ISO 13485:2016 requirements. inspection requirements and GMP standards applicable to your device class and manufacturing scope.

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.

YY/T 0287-2017 and ISO 13485:2016 Equivalence: YY/T 0287-2017 (Quality Management System—Requirements for Medical Device Manufacturers) is the Chinese national standard equivalent to ISO 13485:2016. Both standards define identical QMS requirements across nine main elements: management responsibility, resource management, product realization, measurement/analysis/improvement, design controls, supplier management, production/service control, complaint handling, and post-market surveillance. Manufacturers holding ISO 13485:2016 certification can typically transition to YY/T 0287-2017 compliance with minimal additional effort, as the substantive requirements are aligned. However, NMPA expects QMS documentation to be available in Chinese, and some post-market surveillance requirements may be more stringent under NMPA oversight than ISO 13485 alone requires. Manufacturers registered with NMPA should ensure their QMS explicitly addresses MDSAR 2021 and NMPA-specific expectations (e.g., adverse event reporting to NMPA, compliance with Chinese labeling requirements, supplier traceability). Many manufacturers maintain dual certification to ISO 13485:2016 and YY/T 0287-2017 to facilitate global registration.