China: New Standards for Medical Devices License and Filing Data Management

On 28 July 2025, the National Medical Products Administration (NMPA) officially issued two new information standards that will come into effect immediately. These standards are designed to enhance regulatory oversight, unify data management, and improve transparency in the medical device sector: Basic dataset for medical device manufacturing license and filing management & Basic dataset for medical device distributing license and filing management.

Why These Standards Matter

The medical device industry in China has experienced rapid growth in recent years, bringing with it challenges in regulatory supervision, data consistency, and cross-agency information sharing. By standardizing the basic datasets for both manufacturing and distribution, NMPA aims to:

• Ensure consistency in how license and filing information is recorded and exchanged.

• Facilitate digital supervision and cross-platform data sharing.

• Improve traceability and transparency in medical device production, circulation, and online sales.

• Strengthen compliance requirements for both manufacturers and distributors.

  
  

Key Highlights from the New Standards

• Unified Data Frameworks

  • Both standards define detailed datasets covering license issuance, applications, renewals, cancellations, and modifications.

  • Information includes enterprise registration details, license numbers, production/distribution addresses, storage facilities, business scope, and responsible personnel, and validity periods.

    
    

• Expanded Scope

  • The manufacturing dataset includes data subsets for production licenses, product ranges, application processes, and filing records.

  • The distribution dataset covers wholesale and retail licenses, filing of online sales, third-party e-commerce platform records, and warehouse management across administrative regions.

    
    

• Digitalization and Interoperability

  • The standards adopt uniform data formats (example: character, integer, floating-point, binary, date-time, Boolean) and coding rules

  • This supports automation, system interoperability, and future integration with NMPA’s digital regulatory platforms.

    
    

• Enhanced Compliance Requirements

  • Enterprises must submit structured information, including qualification documents, warehouse details, quality management records, and personnel credentials.

  • Online medical device transactions are specifically addressed, with requirements for reporting sales information and third-party platform filings.

    
    

Implications for the Industry

For manufacturers, the new rules mean clearer requirements when applying for licenses, renewing them, or updating production scope. Compliance will require accurate and standardized data submission.

For distributors and online platforms, the dataset introduces more stringent filing and reporting obligations, particularly in cross-regional storage and e-commerce transactions.

For regulators, the standards pave the way toward a unified national database, enabling stronger risk monitoring, faster approvals, and better alignment with international regulatory practices.

Conclusion

The release of new standard guidelines marks another step in China’s journey to modernize medical device regulation through digital governance. By aligning licensing and filing processes with standardized data requirements, NMPA is reinforcing transparency, compliance, and innovation in the industry.

Stakeholders, including manufacturers, distributors, and online platforms, should review these new standards closely and prepare for compliance to ensure smooth operations under the updated regulatory framework.

Source: National Medical Products Administration (NMPA)