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

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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

  1. 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.
  2. 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.
  3. 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.
  4. 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

Policy Analysis and Guidance: Jiangsu Province’s Medical Device Quality and Safety Assessment Measures

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Jiangsu Provincial Drug Administration has issued new measures for assessing the quality and safety responsibilities of medical device manufacturers. The “Jiangsu Province Medical Device Production Enterprises Quality and Safety Main Responsibility Assessment Measures” aim to strengthen enterprises’ responsibility for quality and safety, enhance regulatory precision, and promote the high-quality development of the medical device industry.

Key Policy Measures

  1. Annual Assessment System
    • Frequency: Enterprises are assessed annually based on their performance in fulfilling quality and safety responsibilities.
    • Scope: The assessment covers the period from January 1 to December 31 of the previous year. New enterprises and those that have been out of production for over a year are excluded.
  2. Three-Tier Grading System
    • Grades: Enterprises are classified into three levels: A (excellent), B (good), and C (average).
    • Criteria:
      – A Grade: Score of 90 or above.
      – B Grade: Score between 75 and 89.
      – C Grade: Score below 75.
  3. Immediate Downgrade Mechanism
    • Circumstances: Enterprises found with serious violations, product quality issues leading to severe incidents, or failure to recall defective products will be immediately downgraded to C.
  4. Self-Assessment and Reporting
    • Process: Enterprises must complete self-assessment by March 31 each year and submit reports to the provincial drug administration’s regulatory platform.
  5. Regulatory Review and On-Site Inspection
    • Procedure: Local market supervision bureaus and inspection branches will review self-assessment reports and conduct on-site inspections on no less than 3% of enterprises by May 31.
  6. Incentive and Constraint Mechanisms
    • Measures: Enterprises of different grades will face corresponding incentives or constraints to encourage continuous improvement in quality and safety management.

Policy Orientation and Industry Implications
The new assessment measures highlight Jiangsu’s strategic focus on:

  • Quality and Safety: Prioritizing product reliability and consumer protection.
  • Regulatory Precision: Enhancing the scientific and precise nature of industry oversight.
  • Industry Upgrading: Driving the medical device sector toward higher quality and innovation.-China Health Reform Pulse

Policy Source: http://da.jiangsu.gov.cn/art/2025/3/28/art_84620_11527826.html

Policy Analysis and Guidance: China Approves Elbasvir for HCV Treatment

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China’s National Medical Products Administration (NMPA) has approved Elbasvir, an innovative 1-class drug developed by YiChang HEC ChangJiang Pharmaceutical Co., Ltd. This drug, to be marketed under the brand name Dongyinghe, is indicated for the treatment of adult chronic hepatitis C virus (HCV) infections in genotypes 1, 2, 3, and 6, including patients with compensated liver cirrhosis. The approval highlights China’s ongoing commitment to enhancing pharmaceutical innovation and regulatory efficiency.

Key Policy Highlights

  1. Innovative Treatment Option
    • Indication: Elbasvir is approved for use in combination with netasavir capsules to treat HCV infections, offering a new therapeutic choice for patients.
    • Patient Population: Targets both treatment-naïve and interferon-treated patients, expanding accessibility to effective therapy.
  2. Regulatory Efficiency
    • Approval Process: The rapid approval reflects NMPA’s efforts to accelerate the market entry of innovative drugs, aligning with global regulatory standards and practices.
  3. Market Implications
    • Therapeutic Landscape: Elbasvir’s entry diversifies treatment options for HCV, potentially improving patient outcomes and reducing the disease burden.
    • Competitive Edge: The drug’s approval underscores China’s progress in developing domestically innovated therapies competitive with international standards.

Policy Orientation and Industry Implications
The approval of Elbasvir underscores China’s strategic focus on:

  • Innovation Support: Encouraging domestic R&D of first-in-class drugs to address unmet clinical needs.
  • Regulatory Streamlining: Accelerating approval processes to bring novel therapies to market faster.
  • Public Health Impact: Enhancing treatment accessibility and outcomes for HCV patients, contributing to public health goals.

Conclusion
Elbasvir’s approval marks another milestone in China’s journey toward becoming a global leader in pharmaceutical innovation. This development not only benefits HCV patients by providing a new treatment option but also signals China’s growing capability in developing and regulating innovative therapies. Stakeholders in the healthcare sector should leverage this momentum to drive further advancements in drug development and regulatory science.-China Health Reform Pulse

Policy Source: https://www.nmpa.gov.cn/zhuanti/cxylqx/cxypxx/20250327113342139.html