Author Archives: wesley

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 & Guidance: Shanghai’s Expansion of Public Insurance to Include 14 Retail Pharmacies

Shanghai’s Medical Insurance Center has announced plans to include 14 retail pharmacies in the city’s public insurance coverage, marking a strategic move to enhance pharmaceutical accessibility and convenience for residents. The proposed additions, spanning multiple districts including Xuhui, Changning, and Jinshan, reflect Shanghai’s commitment to expanding healthcare services amid rising public health demands.

Policy Breakdown

Pharmacies Included: The list features well-known chains such as Lao Bai Xing Pharmacy and Yifeng Pharmacy, with locations in both urban and suburban areas.
Public Consultation Period: A seven day public consultation runs from March 31 to April 7, allowing residents to voice concerns via the 12393 hotline.
Regulatory Basis: The move adheres to national and municipal protocols for medical institution contract management, emphasizing quality assessments and service capacity.

Market Implications
The expansion could significantly boost patient access to subsidized medications, particularly in suburban districts like Jiading and Jinshan. Analysts at Shanghai Healthcare Research Institute estimate a potential 20–25% increase in prescription volumes at newly covered pharmacies.

Consumer Impact
Residents will gain easier access to insured medications, reducing out-of-pocket expenses. This aligns with Shanghai’s 2025 healthcare goals, which prioritize decentralized pharmaceutical networks to support aging-in-place initiatives.

Industry Reaction
Private pharmacy operators are monitoring the policy closely. “Expanded public coverage could compress margins for premium private pharmacies but may also clarify market segmentation,” said Chen Li, CEO of Elite Healthcare Group.

Looking Ahead
Final approval is expected by mid-April, with implementation phased in over six months. Investors should track how reimbursement rates for retail pharmacies compare to private sector pricing, potentially influencing future market entry strategies.

For detailed pharmacy addresses and service scopes, refer to the official announcement document.-China Health Reform

Policy Source: https://ybj.sh.gov.cn/gsgg/20250331/5357a63f70284866b5cee072e6ceecd5.html

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