Category Archives: Sichuan

Policy Analysis and Guidance: Sichuan’s Class II Medical Device Registration Information Disclosure

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

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.
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 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

Policy Analysis and Guidance: Sichuan’s Internet Drug and Medical Device Information Service Filing Announcement

Sichuan Provincial Drug Administration has released the Internet Drug and Medical Device Information Service Filing Information Announcement (Issue 12, 2025). This initiative aims to regulate online information services for drugs and medical devices, ensuring compliance and transparency.

Key Policy Highlights

Filing Requirements
- Compliance: Enterprises must comply with national regulations for internet drug and medical device information services.
- Transparency: Detailed filing information, including enterprise details, website information, and service nature, must be submitted and made public.
Filing Process
- Efficiency: Timely processing of filing applications to ensure market agility.
- Clarity: Clear guidelines on the required materials and procedures for filing.
Market Supervision
- Regulation: Enhanced supervision to ensure all online information services are properly filed.
- Penalties: Strict measures against non-compliant entities to maintain market order.

Policy Orientation and Industry Implications
The filing policy reflects Sichuan’s strategic focus on:

Market Regulation: Ensuring all online drug and medical device information services are properly regulated.
Transparency: Promoting openness and accessibility of information to build consumer trust.
Industry Development: Supporting the healthy development of the online pharmaceutical and medical device sectors through clear regulatory frameworks.

Conclusion
Sichuan’s approach to internet drug and medical device information service filing sets a benchmark for regional regulation, emphasizing compliance, transparency, and market order. Enterprises in the sector should align with these guidelines to ensure smooth operations and consumer trust.-China Health Reform Pulse

Policy Source: http://yjj.sc.gov.cn/scyjj/c103178/2025/3/31/43c0e1a5507c48c8986135c62301627f.shtml

Policy Analysis and Guidance: Sichuan’s Drug and Medical Device Advertising Review Announcement

Sichuan Provincial Drug Administration has released the advertising review information announcement for drugs and medical devices (Issue 12, 2025). This initiative aims to ensure the legality and accuracy of advertising content, Maintain market order, and protect consumer rights.

Key Policy Highlights

Review Criteria
- Legality: Advertisements must comply with national drug and medical device advertising laws and regulations.
- Accuracy: Ad content must accurately reflect product information, avoiding misleading or false claims.
Review Process
- Transparency: The review process is open and transparent, with detailed information on reviewed products and enterprises publicly available.
- Efficiency: Timely review and decision-making to ensure market agility and responsiveness.
Market Supervision
- Regulation: Enhanced supervision to ensure compliance with advertising standards.
- Penalties: Strict penalties for non-compliant advertisements to maintain market integrity.

Policy Orientation and Industry Implications
The advertising review policy reflects Sichuan’s strategic focus on:

Consumer Protection: Ensuring consumers have access to accurate and truthful product information.
Market Integrity: Promoting fair competition and preventing misleading advertising practices.
Regulatory Efficiency: Streamlining the review process to support industry development and innovation.

Conclusion
Sichuan’s approach to drug and medical device advertising review sets a benchmark for regional regulation, emphasizing legality, accuracy, and market integrity. Stakeholders in the pharmaceutical and medical device sectors should align with these guidelines to maintain compliance and consumer trust.-China Health Reform Pulse

Policy Source: http://yjj.sc.gov.cn/scyjj/c103179/2025/3/31/d2372efe246a44b5bf465e68ff31497d.shtml