Category Archives: HSA

NMPA and SAMR Discipline Body Hold Half‑Year Governance Meeting – Innovation Support for Drugs and Medical Devices Takes Center Stage

Meeting Snapshot

Item	Detail
Date	15 September 2026
Convening Bodies	NMPA Party Group; Discipline Inspection and Supervision Group stationed at SAMR (CCDI/NSC)
Format	Regular half‑year consultation meeting on comprehensive strict Party governance
Core Agenda	Political oversight plus dedicated consultation on supporting innovative drugs and medical devices
Key Attendees	Lin Guoyao (SAMR supervision group head); Huang Guo (NMPA Party Group Secretary & Administrator); NMPA Party Group members Lei Ping, Yang Sheng, Wang Weidong; heads of relevant NMPA departments and directly affiliated units
Stated Results	Progress report on H1 2026 consultation tasks; deployment of supervisory recommendations for H2

Supervisory Assessment – Lin Guoyao

Reform Track Record: The NMPA has deepened review and approval reform under the “Four Strictest” requirements — strictest standards, supervision, punishment, and accountability — driving year‑on‑year growth in approvals of innovative drugs and devices, described as an “acceleration” in promoting innovation, while acknowledging remaining shortcomings.
Execution Discipline: Strengthen organizational leadership and reform‑advancement mechanisms, with enhanced inspection, tracking, and accountability to implement reform tasks in detail.
Development–Safety Balance: Proactively empower innovative drug and device R&D while comprehensively upgrading drug safety regulatory capacity to detect and处置 risks early.
“Three‑Medical” Coordination: More actively integrate into the coordinated development and governance of healthcare, medical insurance, and pharmaceuticals, align regulation with clinical needs, and guide local coordination of reform measures.
Global Engagement: Deepen international regulatory cooperation and mutual recognition, assess industry trends precisely, and integrate further into global drug and device safety governance.
Regulatory Science & Talent: Promote deep integration of regulatory science with industrial development and implement the guidance on strengthening drug regulation talent work in the new era.

NMPA Deployment – Huang Guo

H1 Review: Reported progress on H1 2026 consultation tasks and the NMPA’s work supporting innovative development across drugs, medical devices, and cosmetics; deployed implementation of the supervision group’s recommendations.
“Service + Review & Approval” Mechanism: Refine the new service‑oriented approval mechanism to encourage pharmaceutical R&D innovation, advance cell and gene therapy drug development and new‑method research, and support high‑level self‑reliance in medical devices.
Lifecycle Regulation: Strengthen full‑lifecycle oversight — institutionalize drug safety risk consultation, intensify quality supervision of centrally procured (VBP) winning products, and enhance post‑market monitoring and evaluation of innovative products.
Modernization & AI: Advance modernization of drug regulation, deepen the application of artificial intelligence in regulatory work, intensify regulatory science research, and participate deeply in global drug safety governance.
Strict Governance: Compact political responsibility for Party administration, maintain a high‑pressure anti‑corruption posture, continue the “Qinglang Yaojian” (Clear and Bright Drug Regulation) special campaign, and improve constraints and supervision over the exercise of power.

Industry Impact & Outlook

Approval Momentum: The leadership’s framing — rising innovative drug and device approval counts attributed to sustained review‑reform “acceleration” — signals continuity of the pro‑innovation approval posture into H2 2026 and beyond.
Frontier Modalities: Explicit backing for cell and gene therapy development and device self‑reliance points to sustained policy support for advanced‑therapy sponsors and domestic device manufacturers.
VBP Quality Scrutiny: Heightened supervision of centrally procured winning products raises the compliance bar for manufacturers holding volume‑based procurement awards — quality performance will be watched as closely as price.
AI‑Enabled Regulation: Deepening AI application in regulatory work suggests evolving review workflows and data expectations for industry submissions.
Governance Overlay: The coupling of Party‑governance discipline with regulatory policy underscores that reform execution and anti‑corruption compliance remain central to the NMPA’s operating model.

Forward‑Looking Statements
This brief contains forward‑looking statements regarding NMPA regulatory reform priorities, supervision of innovative drugs and medical devices, and governance initiatives for the second half of 2026. Actual implementation may differ based on policy decisions, supervisory review outcomes, and evolving regulatory practice.-China Health Reform Pulse

Policy Source: https://www.cmde.org.cn/xwdt/zxyw/20260916083706136.html

CMDE Opens Public Consultation on AI Medical Device Registration Review Guidance – NMPA’s 2026 Update for AI‑Powered MedTech

Regulatory Milestone

Item	Detail
Agency	CMDE, under NMPA (China)
Action Type	Open public consultation on draft registration review guidance
Document	Guidance Principles for the Registration Review of Artificial Intelligence Medical Devices (Revised Edition 2026) (Draft for Public Comment)
Issuance Date	14 Sep 2026
Comment Deadline	12 Oct 2026, via email using the official feedback form
Contact	Peng Liang — +86‑10‑86452602 — pengliang@cmde.org.cn
Next Steps	CMDE 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, reflecting the agency’s ongoing effort to modernize technical review requirements for a rapidly evolving technology class.
Scope: The guidance governs registration review of artificial intelligence medical devices — software and devices incorporating AI/ML algorithms used for purposes such as medical image analysis, decision support, and clinical workflow assistance — establishing review expectations for safety, efficacy, and quality across the product lifecycle.
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 contact before the 12 October 2026 deadline.
Source: cmde.org.cn official notice

Market Impact & Outlook

Sector Significance: AI medical devices are among the fastest‑growing segments of China’s MedTech industry, spanning AI‑assisted imaging diagnostics, triage and workflow software, and decision‑support algorithms; a revised registration review framework directly shapes time‑to‑market for domestic AI startups and multinational device companies alike.
Compliance Relevance: Developers with pending or planned Class II/III AI device registrations should review the draft early and assess potential impacts on validation datasets, algorithm change control, and clinical evaluation strategies already in their dossiers.
Industry Participation Window: Stakeholders have approximately four weeks to submit structured feedback — an opportunity for AI‑MedTech companies, hospitals, research institutions, and testing bodies to help shape review expectations before the guidance is finalized.
Regulatory Trajectory: The 2026 revision continues NMPA’s pattern of periodically updating its AI medical device guidance to keep pace with algorithm advances and international regulatory practice; the final version, key changes from prior editions, and the effective date have not yet been disclosed.

Forward‑Looking Statements
This brief contains forward‑looking statements regarding regulatory timelines, the finalization of the draft guidance, and its potential impact on AI 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 or technology standards.-China Health Reform Pulse

Policy Source: https://www.cmde.org.cn/flfg/zdyz/zqyjg/20260914160636102.html

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

Regulatory Milestone

Item	Detail
Agency	CMDE, under NMPA (China)
Action Type	Open public consultation on draft registration review guidance
Document	Guidance on the Registration Review of Service Life for Active Medical Devices (Revised Edition 2026) (Draft for Public Comment)
Issuance Date	11 Sep 2026 (published online 14 Sep 2026)
Comment Deadline	9 Oct 2026, via email using the official feedback form
Contacts	Zheng Chen / Zhu Yu — +86‑10‑86452606; +86‑10‑86452851 — zhengchen@cmde.org.cn; zhuyu@cmde.org.cn
Next Steps	CMDE 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