Sichuan Provincial Drug Administration has released the Medical Device Export Sales Certification Information Announcement (Issue 9, 2025). This initiative aims to provide transparent and accurate information on medical device exports, supporting international market access and enhancing the global competitiveness of domestic medical device enterprises.

Key Policy Highlights

1. Certification Information Disclosure
   • Purpose: To provide the public and international markets with accurate information on certified medical devices.
   • Details: The announcement includes detailed certification information for multiple medical device companies, such as Sichuan Bomestar Dental Equipment Co., Ltd.
2. Regulatory Compliance
   • Standards: Ensuring all exported medical devices comply with national standards and regulations.
   • Transparency: Making certification information publicly available to enhance trust and facilitate international trade.
3. International Market Support
   • Development: Supporting the international expansion of the medical device industry through clear and efficient certification processes.
   • Efficiency: Streamlining the certification process to reduce administrative burdens and promote industry growth.

Policy Orientation and Industry Implications
The export sales certification policy reflects Sichuan’s strategic focus on:

• Transparency: Ensuring public and international access to accurate certification information.
• Compliance: Strengthening regulatory frameworks to ensure product safety and quality.
• Global Competitiveness: Supporting the international development of the medical device sector.

Conclusion
Sichuan’s approach to medical device export sales certification sets a benchmark for regional medical device regulation, emphasizing transparency, compliance, and global competitiveness. Medical device enterprises should align with these guidelines to ensure smooth international operations and build global trust.-China Health Reform Pulse

Policy Source: http://yjj.sc.gov.cn/scyjj/c103180/2025/3/31/8af3a8ea68e1418e93cbeb6915ed4ce7.shtml

Sichuan Provincial Drug Administration has released the registration information disclosure for Class II medical devices from March 24 to 28, 2025. This initiative aims to enhance transparency, ensure public access to accurate registration information, and support the healthy development of the medical device industry.

Key Policy Highlights

1. Registration Information Disclosure
   • Purpose: To provide the public with accurate and timely information about Class II medical device registrations.
   • Details: The disclosure includes detailed registration information for multiple medical device companies, such as Chengdu Aikesilun Medical Technology Co., Ltd. and Maccura Biological Co., Ltd.
2. Regulatory Compliance
   • Standards: Ensuring all registered medical devices comply with national standards and regulations.
   • Transparency: Making registration information publicly available to enhance trust and facilitate industry supervision.
3. Industry Support
   • Development: Supporting the innovation and development of the medical device industry through clear and efficient regulatory processes.
   • Efficiency: Streamlining the registration process to reduce administrative burdens and promote industry growth.

Policy Orientation and Industry Implications
The registration information disclosure policy reflects Sichuan’s strategic focus on:

• Transparency: Ensuring public access to accurate and timely registration information.
• Compliance: Strengthening regulatory frameworks to ensure product safety and quality.
• Industry Growth: Supporting the innovation and sustainable development of the medical device sector.

Conclusion
Sichuan’s approach to Class II medical device registration information disclosure sets a benchmark for regional medical device regulation, emphasizing transparency, compliance, and industry support. Medical device enterprises should align with these guidelines to ensure smooth operations and build public trust.-China Health Reform Pulse

Policy Source: http://yjj.sc.gov.cn/scyjj/c103181/2025/3/31/048eeedf0f8b493f88e66ba834eff0c3.shtml