Category Archives: Other

Policy Analysis and Guidance: Guangdong Province’s Volume-Based Drug Procurement Initiative

Guangdong Province’s Drug Exchange Center has issued a notice outlining the implementation details of the centralized volume-based procurement initiative for medications such as Apixaban tablets. This policy, effective from April 1, 2025, to December 31, 2025, aims to streamline drug procurement processes, enhance supply chain stability, and ensure quality assurance across healthcare institutions.

Key Policy Measures

Tripartite Contract Signing
- Process: Medical institutions must use CA certificates to log into Guangdong’s tender and procurement subsystem to initiate tripartite contracts. Detailed operational guidance is available on the official website.
- Timeline: Contracts must be completed promptly after initiation by medical institutions, with drug manufacturers and distributors required to log in and finalize agreements without delay.
Quality and Supply Responsibility
- Accountability: Drug manufacturers are designated as the primary responsible parties for ensuring the quality and timely delivery of medications. They must guarantee coverage of all participating healthcare institutions across the province.
- Compliance: Selected manufacturers must adhere to agreed-upon procurement volumes and ensure uninterrupted supply chains.
Procurement Volume Negotiation
- Flexibility: For designated social healthcare institutions, procurement volumes will be determined through negotiations between supply and demand parties, allowing for tailored agreements.

Policy Orientation and Industry Implications
This initiative reflects Guangdong’s strategic focus on:

Cost Efficiency: Reducing drug prices through centralized procurement while maintaining quality standards.
Supply Chain Integrity: Ensuring uninterrupted medication supply to healthcare facilities across the province.
Transparency: Promoting clear contractual agreements and accountability mechanisms.

Conclusion
Guangdong’s volume-based procurement framework sets a benchmark for regional drug management, emphasizing efficiency, quality, and accessibility. Stakeholders, including manufacturers, distributors, and healthcare providers, should align their operations with these guidelines to optimize compliance and patient outcomes.-China Health Reform Pulse

Policy Source: https://www.gdmede.com.cn/announcement/announcement/detail?id=1906642648857317376

Policy Analysis and Guidance: Sichuan’s Medical Device Export Sales Certification Announcement

Sichuan Provincial Drug Administration has released the Medical Device Export Sales Certification Information Announcement (Issue 9, 2025). This initiative aims to provide transparent and accurate information on medical device exports, supporting international market access and enhancing the global competitiveness of domestic medical device enterprises.

Key Policy Highlights

Certification Information Disclosure
- Purpose: To provide the public and international markets with accurate information on certified medical devices.
- Details: The announcement includes detailed certification information for multiple medical device companies, such as Sichuan Bomestar Dental Equipment Co., Ltd.
Regulatory Compliance
- Standards: Ensuring all exported medical devices comply with national standards and regulations.
- Transparency: Making certification information publicly available to enhance trust and facilitate international trade.
International Market Support
- Development: Supporting the international expansion of the medical device industry through clear and efficient certification processes.
- Efficiency: Streamlining the certification process to reduce administrative burdens and promote industry growth.

Policy Orientation and Industry Implications
The export sales certification policy reflects Sichuan’s strategic focus on:

Transparency: Ensuring public and international access to accurate certification information.
Compliance: Strengthening regulatory frameworks to ensure product safety and quality.
Global Competitiveness: Supporting the international development of the medical device sector.

Conclusion
Sichuan’s approach to medical device export sales certification sets a benchmark for regional medical device regulation, emphasizing transparency, compliance, and global competitiveness. Medical device enterprises should align with these guidelines to ensure smooth international operations and build global trust.-China Health Reform Pulse

Policy Source: http://yjj.sc.gov.cn/scyjj/c103180/2025/3/31/8af3a8ea68e1418e93cbeb6915ed4ce7.shtml

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