Category Archives: HSA

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

Shanghai Publishes Medical Insurance Catalogue of Medical Consumables – Zero‑Margin Sales, Mandatory Sunshine Procurement and Class A/B Reimbursement From 6 November 2026

Policy Milestone

Item	Detail
Issuing Agencies	Shanghai Healthcare Security Administration; Shanghai Municipal Health Commission
Document	Catalogue of Medical Consumables for Shanghai Medical Institutions’ Medical Insurance (2026 Edition) – issued 2 Sep 2026
Policy Basis	NHSA and seven other departments’ Pilot Program for Deepening Medical Service Price Reform (Yi Bao Fa [2021] No. 41)
Catalogue Structure	Formulated in units of the national medical insurance medical consumables classification; subject to dynamic adjustment
Procurement Rule	Catalogued consumables: full‑volume online sunshine procurement + zero‑margin sales; compliance with municipal listing/price‑negotiation and insurance payment rules
Reimbursement Classes	Class A: paid per basic medical insurance rules. Class B: patient pays 20% cash upfront, remainder paid per basic medical insurance rules
Effective Date	6 November 2026; prior inconsistent provisions superseded
Repealed Document	Notice on Publishing the Catalogue of Single‑Use Medical Devices Eligible for Separate Charging (Hu Yi Bao Jia Cai [2019] No. 84)

Catalogue Framework & Billing Rules

Classification‑Based Design: The Shanghai catalogue is built unit‑by‑unit on the national medical insurance consumables classification system, ensuring alignment with national coding, and will be dynamically adjusted as the market and clinical practice evolve.
“Basic Consumables” Prohibition: When delivering care, medical institutions must provide consumables already included in the “basic consumables” component of medical service price items – they may not require patients to self‑procure such items or charge for them separately.
Sunshine Procurement & Zero Margin: All catalogued consumables must be purchased entirely online through transparent procurement channels and sold to patients at zero markup, following Shanghai’s rules on listing, price negotiation and insurance payment.
Class A/B Payment Mechanics: Class A consumables are reimbursed directly under Shanghai’s basic medical insurance regulations; Class B consumables require the insured patient to first bear 20% in cash, classified as a self‑pay share, with the remaining cost then reimbursed per standard rules.

Exemptions & Special Populations

Excluded Groups: The proportional Class B co‑payment rules apply to Shanghai basic medical insurance participants, except veteran Red Army soldiers, retired cadres and disabled veterans graded 1–6, who are exempt.
Mutual‑Aid Plan: Participants in the Shanghai Community Medical Mutual‑Aid Assistance Program follow the same rules by reference.
VBP Products: Payment methods for medical consumables covered by national, alliance‑level and Shanghai‑organized volume‑based procurement are governed by their respective existing regulations.

Market Impact & Outlook

End of Separate‑Charging Era for Listed Devices: Abolishing the 2019 separately chargeable single‑use device catalogue and replacing it with a unified insurance catalogue removes a legacy add‑on billing channel, tightening hospital revenue from consumables and shifting the margin burden entirely off patients for basic consumables.
Zero‑Margin Discipline: Mandatory zero‑margin sales plus full‑volume online sunshine procurement eliminate hospital mark‑up incentives on catalogued consumables, reinforcing the national “zero‑markup” consumables policy and pushing supplier competition onto listed prices.
Class B Co‑Pay Certainty: A uniform 20% upfront self‑pay ratio for Class B consumables gives manufacturers and hospitals a predictable reimbursement structure – but keeps cost‑sensitivity high for premium‑priced Class B products.
National Coding Convergence: Building the catalogue on the national classification deepens Shanghai’s alignment with NHSA‑led consumables governance, easing cross‑province comparability and future national catalogue integration.
Implementation Window: Hospitals and suppliers have roughly two months (to 6 November 2026) to remap billing systems, procurement workflows and product listings to the new catalogue.

Forward‑Looking Statements
This brief contains forward‑looking statements regarding the implementation of the Shanghai medical insurance medical consumables catalogue, including procurement compliance, reimbursement operations and dynamic catalogue adjustments. Actual outcomes may differ due to risks including implementation execution by medical institutions, supplier listing and pricing adjustments, and subsequent policy updates by national or municipal authorities.-China Health Reform Pulse

Policy Source: https://ybj.sh.gov.cn/qtwj/20260911/ea41e7ead0ff4f60b191f07967d71a5f.html