Tag Archives: Digital Health

CMDE Opens Public Consultation on Active Medical Device Service Life Guidance – NMPA’s 2026 MedTech Registration Review Update

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Beijing, China – 11 Sep 2026 – The Center for Medical Device Evaluation (CMDE), the technical review arm of China’s National Medical Products Administration (NMPA), announced an open public consultation on the “Guidance on the Registration Review of Service Life for Active Medical Devices (Revised Edition 2026) (Draft for Public Comment),” with stakeholder feedback due by 9 October 2026.

Regulatory Milestone

ItemDetail
AgencyCMDE, under NMPA (China)
Action TypeOpen public consultation on draft registration review guidance
DocumentGuidance on the Registration Review of Service Life for Active Medical Devices (Revised Edition 2026) (Draft for Public Comment)
Issuance Date11 Sep 2026 (published online 14 Sep 2026)
Comment Deadline9 Oct 2026, via email using the official feedback form
ContactsZheng Chen / Zhu Yu — +86‑10‑86452606; +86‑10‑86452851 — zhengchen@cmde.org.cn; zhuyu@cmde.org.cn
Next StepsCMDE to review submitted comments and finalize the 2026 revised guidance

Guidance Profile & Regulatory Background

  • Revision Mandate: The revision was organized by CMDE in accordance with the NMPA’s standing program for the development and amendment of medical device registration review guidance documents, part of a broader, continuous modernization of China’s MedTech technical review framework.
  • Scope: The guidance governs how service life (use period) claims for active medical devices — devices that rely on electrical or other energy sources for operation — should be substantiated and evaluated during registration review in China.
  • Consultation Materials: Two attachments accompany the notice: the draft revised guidance (Attachment 1) and a standardized feedback form (Attachment 2), both downloadable from CMDE’s website.
  • Submission Channel: Comments and suggestions must be completed on the feedback form and emailed to the designated CMDE contacts before the 9 October 2026 deadline.
  • Source: cmde.org.cn official notice

Market Impact & Outlook

  • Compliance Relevance: Service life substantiation is a core component of registration dossiers for active medical devices in China; manufacturers, contract research organizations, and testing institutions should review the draft early and assess potential impacts on existing and planned registration strategies.
  • Industry Participation Window: Stakeholders have approximately four weeks to submit structured feedback — an opportunity for domestic and foreign MedTech companies to help shape review expectations before the guidance is finalized.
  • Regulatory Trajectory: The 2026 revision continues NMPA’s pattern of periodically updating technical review guidance to reflect evolving device technologies and international standards; the final version and its effective date have not yet been disclosed.
  • Pipeline Implications: Once finalized, the revised guidance will apply to new registration submissions for active medical devices and may influence how legacy service life claims are maintained or amended in post‑market regulatory activities.

Forward‑Looking Statements
This brief contains forward‑looking statements regarding regulatory timelines, the finalization of the draft guidance, and its potential impact on medical device registration in China. Actual outcomes may differ due to risks including changes arising from the public consultation process, final agency determinations, and shifts in regulatory policy.-China Health Reform Pulse

Policy Source: https://www.cmde.org.cn/flfg/zdyz/zqyjg/20260914132853156.html

Shenzhen Launches Three‑Year AI Action Plan Targeting ¥300 Billion Core Industry by 2028 – 23 Key Tasks to Fuse AI with Research, Industry, Consumption and City Governance

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Shenzhen, China – 09 Sep 2026 – The Shenzhen Municipal People’s Government has officially released the “Shenzhen Action Plan for Promoting the Development of Artificial Intelligence and Applications (2026–2028)”, a three‑year blueprint targeting an AI core industry scale exceeding ¥300 billion (≈ US$42 billion), more than 3,000 AI enterprises, and an adoption rate above 90% for next‑generation smart terminals and AI agents by 2028, as the city accelerates its bid to become an “AI Pioneer City.”

Policy Snapshot

ItemDetail
Issuing AuthorityShenzhen Municipal People’s Government
PolicyShenzhen Action Plan for Promoting the Development of AI and Applications (2026–2028)
Time Horizon2026–2028
Core Industry TargetAI core industry scale exceeding ¥300 billion by 2028
Enterprise TargetMore than 3,000 AI companies
Adoption Target>90% penetration of next‑generation smart terminals and AI agents
Task Framework23 key tasks across six priority areas
Strategic GoalBuild Shenzhen into an “AI Pioneer City”

Six Priority Areas

  • Scientific Research: Shenzhen will build a “model–data–experiment” trinity technology system for scientific discovery, developing AI‑for‑Science foundation models on innovation platforms including Guangming Science City and Xili Lake International Science & Education City, and accelerating AI applications in biopharmaceuticals, high‑performance materials, and quantum technology.
  • Industrial Empowerment: AI will be embedded across the full advanced‑manufacturing value chain, with a push for industrial AI agents. The plan also drives AI convergence with professional services — finance, software, human resources, law, and accounting — expanding scenarios such as intelligent risk control, AI‑powered investment research, and AI coding.
  • AI‑Native Consumption: The city will foster “AI‑native” consumption, supporting AI phones, AI PCs, AI glasses, and humanoid robots, and exploring new formats such as digital avatars and AI emotional companionship. In culture and tourism, it backs intelligent NPCs, dynamic storylines, and AI comic dramas; in transport and logistics, it will expand last‑mile delivery by autonomous vehicles and drones across communities, business districts, and campuses.
  • People’s Livelihood: AI will empower employment, education, healthcare, elderly care, childcare, and housing. Shenzhen will continue to optimize its “Shen Xiaowei” health agent — offering smart triage, pre‑consultation intake, and medical report interpretation — and explore embodied‑intelligence devices for elder companionship and childcare supervision.
  • Urban Governance: Deep AI integration into city governance is listed among the six priority areas; specific measures were not detailed in the release.
  • Global Cooperation: Leveraging the Qianhai and Hetao platforms, Shenzhen will deepen international collaboration and refine the “Hong Kong R&D + Shenzhen Commercialization” model. Seizing the opportunity of the 33rd APEC Economic Leaders’ Informal Meeting, the city will showcase its AI solutions and push the “China AI stack” to go global, prioritizing Latin America, Southeast Asia, and Central Asia.

Foundation & Support Measures

  • Compute Infrastructure: Accelerate construction of flagship projects including Pengcheng Cloud Brain III.
  • Seven Pillars: Strengthen foundational capabilities in computing power, models, data, scenarios, talent, research platforms, and industrial funds.
  • Commercialization Pipeline: Move AI innovations from the laboratory to industry and urban applications at speed.

Market Impact & Outlook

  • National AI Race: The plan positions Shenzhen among China’s most aggressive municipal AI strategies, pairing a hard ¥300 billion core‑industry target with a 90% adoption benchmark that emphasizes real‑world deployment over pure research output.
  • Hardware Ecosystem Edge: Shenzhen’s consumer‑electronics supply chain — spanning AI phones, AI PCs, smart glasses, and humanoid robotics — gives it a structural advantage in monetizing the next wave of intelligent terminals.
  • Cross‑Border Innovation Model: The “Hong Kong R&D + Shenzhen Commercialization” pipeline, anchored by Qianhai and Hetao, offers a differentiated route for basic‑research translation under the Greater Bay Area framework.
  • Export Ambition: Targeting Latin America, Southeast Asia, and Central Asia, the plan signals a shift from exporting AI hardware to exporting full‑stack AI systems and governance solutions, with the APEC summit as a showcase moment.

Forward‑Looking Statements
This brief contains forward‑looking statements regarding policy implementation timelines, industry scale targets, adoption rates, and commercialization expectations under Shenzhen’s AI Action Plan (2026–2028). Actual outcomes may differ due to risks including execution pace, technology maturation, funding availability, and the evolving global AI regulatory and competitive landscape.-China Health Reform Pulse

Policy Source: https://www.gd.gov.cn/zwgk/zcjd/snzcsd/content/post_4951847.html

Policy Analysis and Guidance: Sichuan’s Internet Drug and Medical Device Information Service Filing Announcement

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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

  1. 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.
  2. Filing Process
    • Efficiency: Timely processing of filing applications to ensure market agility.
    • Clarity: Clear guidelines on the required materials and procedures for filing.
  3. 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