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.
Overviewβ
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 sourceβ
Official texts are published on www.nmpa.gov.cn and the State Council website at www.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.
Scopeβ
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 Requirementsβ
- 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 must not exceed approved indications and contraindications
- Record-keeping: purchase, sale, and recall records retained for minimum 5 years
- Distributor qualification: legal entity status, quality personnel, appropriate facilities
Relationship to MDSAR 2021β
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.