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Operation Supervision & Administration Measures

This page provides a plain English reference for operation supervision & administration measures in China's medical device regulatory framework. Full content to be completed during editorial review.

Overview​

See MDSAR 2021 for the primary regulation. This page covers the implementing measure or standard listed above, explaining its scope, key requirements, and relationship to MDSAR 2021.

Official source​

Official texts are published on www.nmpa.gov.cn and the State Council website at www.gov.cn.

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.

Scope​

This measure implements MDSAR 2021 Chapter IV (Articles 58-72), establishing requirements for medical device business operations, including licensing, storage, distribution, traceability, and advertising compliance.

Key Requirements​

  • Business licence required for manufacturers, distributors, and retailers (Class II/III devices)
  • Traceability system mandatory: manufacturers must track distribution to first recipient; distributors track upstream and downstream
  • Cold chain management and storage conditions per device technical specifications
  • Restricted advertising: promotional claims and advertising content must not exceed the scope of approved indications, contraindications, and precautions stated in the registration certificate; any unauthorized claims constitute regulatory violation
  • Record-keeping: purchase, sale, and recall records retained for minimum 5 years from the date of transaction. Post-market surveillance records for Class III devices retained per NMPA guidance.
  • Distributor qualification: legal entity status, quality personnel, appropriate facilities

Relationship to MDSAR 2021​

This measure operationalizes Article 58 (business licence), Articles 63-65 (traceability), and Article 70 (advertising) of MDSAR 2021 Chapter IV with detailed procedural and technical requirements.