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Policy Analysis and Guidance: Sichuan Provincial Drug Administration’s Policy Update

Sichuan Provincial Drug Administration has released a policy update aimed at enhancing drug regulation and market management. This initiative reflects the province’s commitment to ensuring drug safety, quality, and accessibility for consumers.

Key Policy Highlights

Regulatory Enhancement
- Purpose: Strengthening oversight of pharmaceutical products to ensure compliance with national standards.
- Measures: Implementing stricter inspection and approval processes for drug manufacturers and distributors.
Market Management
- Focus: Addressing market order and ensuring fair competition among pharmaceutical enterprises.
- Actions: Conducting regular market checks and taking action against non-compliant entities.
Consumer Protection
- Safety: Prioritizing consumer safety through rigorous quality control measures.
- Accessibility: Ensuring the availability of essential medications through efficient market management.

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

Quality Assurance: Emphasizing the importance of drug quality and safety.
Regulatory Efficiency: Enhancing the efficiency and effectiveness of regulatory measures.
Market Stability: Ensuring a stable and competitive pharmaceutical market for consumers.

Conclusion
Sichuan’s approach to drug administration policy sets a benchmark for regional regulation, emphasizing quality, safety, and market stability. Stakeholders in the pharmaceutical sector should align with these guidelines to maintain compliance and ensure patient access to essential medications.-China Health Reform Pulse

Policy Source: http://yjj.sc.gov.cn/scyjj/c103182/2025/3/31/85f25c8762c84d31a6f0467d504cd407.shtml

Policy Analysis and Guidance: Xinjiang’s Priority Registration for Medical Device Applications

Xinjiang’s Drug Evaluation and Inspection Center has released a notice on the priority registration application review results for medical devices (2025 No. 1). This initiative aims to expedite the registration process for specific medical devices, reflecting the region’s commitment to supporting innovation and addressing public health needs.

Key Policy Highlights

Priority Registration Criteria
- Basis: Applications are reviewed under the “Xinjiang Uygur Autonomous Region Second-Class Medical Device Special Registration Procedure” (Announcement No. 39, 2021).
- Purpose: To accelerate the registration of devices that meet specific priority criteria.
Publicize Details
- Period: The public announcement period is from March 24 to 28, 2025.
- Content: Lists the product “Electronic Gastroscopy” by Xinjiang Ruijiang Biotechnology Co., Ltd., which qualifies for priority registration due to meeting specific criteria.
Objection Process
- Contact: Stakeholders with objections are encouraged to contact the center within the announcement period.

Policy Orientation and Industry Implications
The priority registration policy reflects Xinjiang’s strategic focus on:

Innovation Support: Accelerating the market entry of innovative medical devices.
Public Health: Addressing urgent public health needs through faster access to critical devices.
Regulatory Efficiency: Streamlining the registration process to support industry development.

Conclusion
Xinjiang’s priority registration initiative for medical devices sets a precedent for regional regulatory support, emphasizing innovation and public health. Companies in the medical device sector should leverage this policy to expedite product development and market entry.-China Health Reform Pulse

Policy Source: http://mpa.xinjiang.gov.cn/xjyjj/ylqxggtg/202503/b44f72f43777439793f7df0b2bb3673d.shtml

Policy Analysis and Guidance: China’s Medical Device Regulation and Innovation Push

On March 29, 2025, Xu Jinghe, Vice Minister of China’s National Medical Products Administration (NMPA), conducted a field research in Qingdao, visiting medical device companies and a hospital to understand the innovation and quality supervision of the medical device industry. Xu emphasized the importance of implementing the “four strictest” requirements, strengthening the quality responsibility system, and promoting innovation in the medical device sector.

Key Policy Highlights

Quality and Safety Supervision
- Stringent Requirements: Adherence to the “four strictest” principles to ensure the safety and quality of medical devices.
- Lifecycle Regulation: Enhancing supervision across the entire lifecycle of medical devices, from production to distribution and usage.
Enterprise Responsibility
- Accountability: Medical device manufacturers are the primary responsible parties for product quality and safety.
- Compliance: Ensuring enterprises strictly comply with regulatory standards and maintain quality management systems.
Support for Innovation
- Mechanism Improvement: Establishing and improving mechanisms to support the development of innovative medical devices.
- Regulatory Capacity: Strengthening the regulatory system and capacity building to facilitate research, development, and innovation in the medical device industry.
Industry Development
- High-Quality Growth: Promoting high-quality development of the medical device industry through policy support and regulatory optimization.

Policy Orientation and Industry Implications
Xu’s research and remarks highlight the Chinese government’s strategic focus on:

Safety Assurance: Prioritizing the safety and quality of medical devices through rigorous regulatory measures.
Innovation Drive: Encouraging innovation to enhance the competitiveness and technological level of the medical device industry.
Industry Support: Creating a favorable policy environment to support the sustainable and high-quality development of the sector.

Conclusion
China’s enhanced focus on medical device regulation and innovation reflects its commitment to improving public health outcomes and fostering a robust medical device industry. Companies in the sector should align with these policy directions to ensure compliance while leveraging innovation to gain a competitive edge in the market.-China Health Reform Pulse

Policy Source: https://www.nmpa.gov.cn/yaowen/ypjgyw/ylqxyw/20250330085803195.html