Sichuan Provincial Drug Administration has released the initial registration product directory for Class II medical devices for March 2025. This initiative aims to enhance transparency, ensure compliance, and support the development of the medical device industry.
Key Policy Highlights
- Registration Information Disclosure
- Purpose: To provide the public with accurate and timely information on newly registered Class II medical devices.
- Details: The directory includes detailed registration information for multiple medical device companies, such as Chengdu Kanghuijing Technology Co., Ltd. and Wangcheng Medical Technology (Chengdu) Co., Ltd.
- 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.
- 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 initial registration product directory 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 initial registration 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/c103181/2025/4/1/53dabb2afc2547e4bbc9a1ed78f3ce27.shtml