Tag Archives: Others

Policy Analysis and Guidance: Sichuan’s Class II Medical Device Initial Registration Product Directory

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

Policy Analysis and Guidance: Yunnan’s Announcement on Credit Rating Notifications for Dishonest Enterprises

Yunnan Provincial Government Procurement and Tendering Center has issued an announcement regarding credit rating notifications for dishonest enterprises involved in pharmaceutical commercial bribery. This initiative aims to strengthen the regulation of the pharmaceutical industry, combat commercial bribery, and maintain market order and fair competition.

Key Policy Highlights

Credit Evaluation
- Objective: To evaluate the credit of enterprises involved in pharmaceutical commercial bribery cases and issue corresponding ratings.
- Basis: The evaluation is conducted in accordance with the “Operational Norms for Pharmaceutical Price and Tendering Credit Evaluation (2020 Edition)”.
Notification and Collection
- Process: Enterprises listed in the announcement must collect their credit rating notifications by April 9, 2025.
- Location: Notifications can be collected at Room 402, Transaction Building, No. 269 Kefa Road, Kunming High-Tech Zone.
Consequences of Non-Compliance
- Deadline: Failure to collect the notification by the specified date may result in adverse consequences for the enterprises involved.

Policy Orientation and Industry Implications
The credit rating policy reflects Yunnan’s strategic focus on:

Market Regulation: Combating commercial bribery to maintain a fair and orderly market environment.
Transparency: Enhancing transparency in the pharmaceutical industry through credit evaluations.
Compliance: Encouraging enterprises to adhere to legal and ethical standards in their operations.

Conclusion
Yunnan’s approach to credit rating notifications for dishonest enterprises sets a benchmark for regional pharmaceutical industry regulation, emphasizing transparency, compliance, and market integrity. Enterprises in the sector should align with these guidelines to maintain compliance and contribute to a fair market environment.-China Health Reform Pulse

Policy Source: http://www.ynyyzb.com.cn/detail.html?infoId=25193&CatalogId=3

Policy Analysis and Guidance: Guizhou’s Notification on Guiding and Regulating Private Hospital Development

Guizhou Province’s Health Commission, Medical Insurance Bureau, and Traditional Chinese Medicine Bureau have issued a notification to further guide and regulate the development of private hospitals. This policy aims to promote the healthy, standardized development of private hospitals, enhance medical service quality, and meet the diverse health needs of the public.

Key Policy Highlights

Strengthening Party Leadership
- Organizational Coverage: Expand party organization coverage in private hospitals, establishing separate or joint party organizations based on the number of formal party members.
- Political Core Role: Play the role of party organizations as a political core, ensuring the implementation of party policies and promoting high-quality development through strengthened ideological, cultural, and anti-corruption work.
Regulating Practice Behavior
- Name Standardization: Prohibition misleading names and reserve certain titles exclusive for public healthcare institutions.
- Approval and Verification: Improve approval efficiency and encourage participation in hospital grading evaluations.
- Department Setup: Align department setup with practice scopes and qualifications, prohibiting misleading or unconventional department names.
- Personnel Qualifications: Ensure all medical staff are properly qualified and registered, with a focus on building a structured talent pool.
Enhancing Service Quality
- Quality and Safety Management: Integrate private hospitals into the medical quality management system and establish real-time supervision mechanisms.
- Clinical Technology Application: Standardize the management of medical technologies and surgeries through established directories and dynamic assessments.
- Pharmaceutical and Device Management: Ensure the safety and quality of药品and medical devices, with strict management of high-risk items and traditional Chinese medicine.
- Infection Control: Strengthen hospital infection management through comprehensive systems and staff training.
Supporting Healthy Development
- Specialized Development Guidance: Encourage private hospitals to focus on specialized fields and innovative service models.
- Talent and Specialized Development Support: Provide equal opportunities for private hospital professionals in title evaluations and training.
- Medical Alliance Participation: Support private hospitals in joining medical alliances to promote resource sharing and coordinated development.
- Medical Insurance Policy Support: Facilitate private hospitals’ participation in drug and device procurement and medical insurance services.
Comprehensive Regulation
- Risk Prevention: Establish comprehensive risk management systems to enhance medical safety.
- Regulatory Enforcement: Use various inspection methods to ensure compliance with medical practice and safety standards.
- Information Transparency: Enhance Hospital Information Disclosure Systems to Ensure Accuracy and Prevent Misleading Promotion.
- Credit Evaluation: Implement a credit evaluation system for private hospitals to promote trust and regulatory efficiency.

Policy Orientation and Industry Implications
Guizhou’s policy on guiding and regulating private hospitals reflects a strategic focus on:

Quality Enhancement: Improving medical service quality through rigorous standards and management.
Regulatory Efficiency: Strengthening oversight to ensure compliance and patient safety.
Industry Support: Promoting sustainable growth and innovation in the private hospital sector.

Conclusion
Guizhou’s comprehensive approach to private hospital regulation and support sets a benchmark for regional healthcare management, emphasizing quality, compliance, and industry development. Private hospitals should align with these guidelines to enhance service quality, build public trust, and achieve sustainable growth.-China Health Reform Pulse

Policy Source: https://wjw.guizhou.gov.cn/zwgk/gzhgfxwjsjk/gfxwjsjk/202504/t20250401_87326150.html