Category Archives: HSA

CMDE Opens Consultation on Two Draft Registration Review Guidance Documents for Medical Devices – Software for Laparoscopic Endoscopy Systems and Medical Oxygen Chambers

Beijing, China – 08 Sep 2026 – The Center for Medical Device Evaluation (CMDE) of the National Medical Products Administration (NMPA) has released for public comment two draft registration review guidance documents — “Registration Review Guidelines for Laparoscopic Endoscopy Surgery Systems, Part 6: Software” and “Registration Review Guidelines for Medical Oxygen Chambers” — with feedback due by 8 Oct 2026.

Regulatory Milestone

ItemDetail
Issuing AuthorityCMDE, NMPA
Notice TypePublic consultation on draft registration review guidance
Document 1Registration Review Guidelines for Laparoscopic Endoscopy Surgery Systems – Part 6: Software (Draft for Comments)
Document 2Registration Review Guidelines for Medical Oxygen Chambers (Draft for Comments)
Policy BasisNMPA work plan for formulation and revision of medical device registration review guidance
Publication Date8 Sep 2026
Comment Deadline8 Oct 2026
Submission MethodCompleted feedback form (Attachment 3) by email, with subject/file naming convention

Guidance Documents Under Consultation

  • Laparoscopic Endoscopy Software (Part 6): The draft addresses the software component of laparoscopic endoscopy surgery systems — in China’s classification, the device category that also covers robot‑assisted minimally invasive surgery systems. As the sixth part of a multi‑part guidance series, it is set to standardize registration review expectations for system software, a critical compliance reference for both domestic surgical‑robot developers and imported platforms seeking NMPA clearance.
  • Medical Oxygen Chambers: The draft provides dedicated registration review guidance for hyperbaric oxygen therapy chambers, a device class spanning hospital‑grade multi‑place chambers and smaller monoplace units used in clinical oxygen therapy. Final guidance will give manufacturers a consolidated benchmark for technical documentation, safety and performance review.

Feedback Procedure

  • Form Requirement: Comments must be submitted on the official feedback form (Attachment 3); both draft guidance texts are available for download alongside the notice.
  • Naming Convention: Email subjects and file names must follow the format “Feedback Organization + 《Guidance Title》 Feedback.”
  • Contact – Document 1 (Endoscopy Software): Mr. Zhang Chenguang, tel. 010‑86452649, email zhangcg@cmde.org.cn.
  • Contact – Document 2 (Oxygen Chambers): Mr. Liu Xiaoyin and Ms. Wu Jiangyan, tel. 010‑86452634 / 021‑68662198, emails liuxy1@cmde.org.cn and wujy@ydcmdei.org.cn — the Shanghai‑area contact indicating co‑drafting input from a regional evaluation partner.

Market Impact & Outlook

  • Surgical Robotics Compliance Roadmap: For developers in China’s fast‑expanding laparoscopic surgical‑robot sector, Part 6 on software will sharpen expectations on software description, versioning, cybersecurity and standalone‑software documentation — reducing registration ambiguity but raising the bar for pre‑submission preparation.
  • Hyperbaric Equipment Standardization: A dedicated guidance for medical oxygen chambers signals maturation of that niche market, with clearer review criteria likely to benefit established manufacturers and streamline entries by new applicants.
  • One‑Month Comment Window: The 8 Oct deadline gives industry a short, defined window to shape final texts; manufacturers and trade associations with pending or planned registrations in either category should review the drafts promptly, as final guidance will directly frame technical review dossiers.
  • Guidance Cadence: The consultation continues the CMDE’s systematic build‑out of device‑category‑specific review guidance under the NMPA’s multi‑year formulation plan, reinforcing a rules‑based, increasingly transparent registration pathway for medical devices in China.

Forward‑Looking Statements
This brief contains forward‑looking statements regarding the consultation process, final content of the two guidance documents, and their impact on device registration timelines. Actual outcomes may differ due to risks including revisions between draft and final versions, feedback evaluation, and subsequent NMPA/CMDE policy actions.-China Health Reform Pulse

Policy Source: https://www.cmde.org.cn/xwdt/zxyw/20260908165732174.html

Shanxi Clarifies Medical Service Pricing Rules for Public Hospitals

Taiyuan, Sept 7, 2026 — The Shanxi Provincial Medical Security Bureau has issued a formal interpretation of its medical service pricing policy (Notice No. 9 of 2026), setting out detailed billing rules for public medical institutions across ten areas—from price-item design and “service output” definitions to surcharge stacking, pricing units and the separation of consumables from clinical services.

Policy Snapshot

AttributeDetail
DocumentInterpretation of Price Policy for Medical Service Projects
ReferenceShanxi Medical Security Bureau Notice No. 9 of 2026
Issuing bodyShanxi Provincial Medical Security Bureau
DateSept 7, 2026 (proactively disclosed)
ScopeBilling and price-item application across public medical institutions in Shanxi
Core principlePrice items anchored to “service output,” not to devices or consumables
Key reformsSeparation of technology and consumables (“技耗分离”); separation of drugs and consumables (“药耗分离”)

Policy Context

The interpretation clarifies how hospitals should apply China’s new project-establishment guidelines for medical service prices. Under the framework, price items are created only where a distinct clinical service output exists: identical outputs from different techniques or pathways must map to a single item, complete procedures cannot be unbilled into steps, and no item may be established around a device or consumable—for instance, arrhythmia ablation is priced as one item regardless of whether radiofrequency, cryo, chemical or pulsed-field energy is used.

The document defines service output across four dimensions—core clinical outcomes, tangible auxiliary outputs such as test reports, patient-experience outputs, and auxiliary operations billed under an “A+B” (procedure plus add-on) model—and lays out anti-duplication rules with concrete examples: CT plain and enhanced scans may stack only when both are actually performed; ICU nursing fees already embed oral and perineal care; manual release cannot be billed alongside same-site traditional Chinese medicine tuina massage.

On pricing units, the bureau details per-session, per-site and progressive-base calculations—ambulance transport charges a base fare covering 4 kilometers plus 3 yuan per additional kilometer, while nerve-block anesthesia bills a two-hour base of 379 yuan plus 149 yuan per additional hour. Surcharge items within the same sequence cannot stack, though cross-sequence surcharges (for example, chief-physician and pediatric add-ons) may combine. The pediatric surcharge applies strictly through age six—until the day before a child’s seventh birthday—and “newborn” items are limited to the first 28 days of life.

Market Impact Analysis

The interpretation operationalizes one of the most consequential shifts in China’s healthcare payment system: the “separation of technology and consumables” principle, which purifies service prices to reflect clinical labor value while making consumable prices explicit and independently managed. By decoupling medical consumables from service items, the policy ends the legacy rule that “no service item, no consumable charge,” laying groundwork for a provincial medical insurance consumables catalog and extending drug-pricing tools—volume-based procurement and catalog management—to devices and disposables.

For hospitals, the document functions as a compliance manual: it resolves recurring billing ambiguities (whether examination fees may be layered onto consultation fees, how mapping items fold into price composition, when re-performed procedures may be billed again) that directly affect revenue integrity under medical insurance audits. The explicit anti-duplication and “basic material consumption” rules—where inclusive but non-analogical interpretation bars separate billing for items like soda lime while allowing distinct high-value devices such as pulse lavage systems—signal tighter scrutiny of unbundling practices.

Provincial-level guidance of this granularity is also a bellwether: as national project-establishment guidelines roll out across China, other provinces are expected to publish similar interpretations, making Shanxi’s framework a reference point for hospital billing systems, medical insurance enforcement and health-economics planning nationwide.

Forward-Looking Statement

Public medical institutions in Shanxi are expected to align billing systems, staff training and internal audit procedures with the interpretation immediately, as the document serves as the operational basis for price execution and insurance fund supervision. Market watchers will monitor whether the clarifications accelerate adoption of the standalone consumables pricing system and how the “service output” consolidation approach shapes future pricing of emerging technologies—including AI-assisted diagnostics and xenotransplantation, which the document already flags as non-separately-billable extensions of existing items. Similar interpretations from other provincial medical security bureaus are anticipated as the national pricing reform deepens toward mid-2027.-China Health Reform Pulse

Policy Source: https://ybj.shanxi.gov.cn/xxfb/xxgkml/202609/t20260907_10215759.html

China Updates DRG, DIP Payment Groups to 3.0 in Healthcare Reform Push

Beijing, Aug 31, 2026 — China’s National Healthcare Security Administration (NHSA) released the 3.0 version grouping schemes for Diagnosis-Related Group (DRG) and Diagnosis-Intervention Packet (DIP) payment systems, expanding coverage to 825 DRG subgroups and 5,125 DIP core disease categories as the nation deepens hospital cost control reforms with a March 2027 implementation deadline.

Policy Snapshot

AttributeDetail
IssuerNational Healthcare Security Administration (NHSA)
Document3.0 Grouping Scheme for DRG and DIP Payment
DRG 3.0492 core ADRG groups; 825 DRG subgroups
DIP 3.05,125 core disease categories
Switch preparation deadlineDec 31, 2026
Implementation deadlineMarch 31, 2027
Primary care diseases31 DRG primary care groups; 127 DIP primary care categories

Key Provisions

  • Implementation timeline — Regions and hospitals using disease-based payment must complete system switching preparation by Dec 31, 2026, and fully deploy the 3.0 grouping by end-March 2027. Provincial authorities may adapt the national framework to local conditions while maintaining consistency with core national DRG groups and DIP categories.
  • Primary care alignment — The 3.0 scheme introduces 31 DRG primary care groups and 127 DIP primary care categories, requiring uniform payment rates for the same disease across hospital tiers within a pooling region. This “same disease, same payment” rule aims to divert patient flow toward grassroots facilities.
  • Data quality mandate — Hospitals must strictly follow national medical insurance settlement list standards, accurately use NHSA diagnostic and procedure codes, and upload settlement data promptly to ensure accurate case grouping.
  • Budget management — Pooling regions must strengthen total expenditure management based on fund budgets, with provisions to reserve a portion of annual funds to balance policy adjustments and service volume fluctuations. Some regions may explore quarterly or monthly allocation of disease-based payment budgets.
  • Payment standard calibration — Provincial authorities should guide pooling regions to calculate disease weights, point values, and payment rates based on fund performance, disease spectrum changes, historical medical data, and medical technology innovation. Flexible rate mechanisms are encouraged, including fixed rates for baseline volumes and floating rates for incremental volumes.
  • Outlier case mechanism — DRG outlier case reviews are capped at 5% of total discharged cases; DIP outlier reviews are adjusted to no more than 1% of discharged cases from 2027. The quota is allocated at the pooling region level rather than evenly distributed across individual hospitals.
  • Settlement efficiency — Regions must advance real-time settlement systems, expand the share of funds settled in real time, and implement a three-year action plan to accelerate clearing and optimize payment structures. Quarterly clearing is encouraged.
  • Surplus and deficit sharing — Hospitals retaining surpluses under the disease-based payment system may use the funds for disciplinary development and staff performance. Reasonable overruns caused by major policy adjustments or infectious disease outbreaks are shared proportionally between the insurance fund and hospitals.
  • Cross-region care — Provinces must unify disease grouping, payment calculation methods, and administrative management for intra-provincial cross-region hospitalization under disease-based payment. Cross-provincial direct settlement under disease-based payment will be gradually advanced.
  • Data transparency — A normalized data publication mechanism will be established through the national medical insurance information platform, with automatic data push and dynamic monitoring. Regions should conduct thematic analysis on at least five high-volume or high-cost diseases annually and share results with designated hospitals.

Market Impact Analysis

The 3.0 grouping represents the most significant refinement of China’s hospital payment reform since the initial DRG/DIP rollout, tightening cost control while introducing flexibility mechanisms to protect clinical innovation and rare cases. The expansion to 825 DRG subgroups and 5,125 DIP categories allows more precise case matching, reducing the “upcoding” and service distortion incentives that plagued broader grouping systems.

The primary care “same disease, same payment” provision is a structural market-shifter. By equalizing reimbursement across hospital tiers for 31 DRG and 127 DIP primary care conditions, regulators are explicitly steering hypertension, diabetes, and common respiratory infections toward community health centers and township hospitals. This threatens revenue streams for tier-two and tier-three hospitals that have historically relied on high outpatient volumes for chronic disease management.

The outlier case caps—5% for DRG and 1% for DIP—strike a balance between cost discipline and clinical reality, though the low DIP threshold may pressure hospitals to avoid complex cases or shift them to non-DIP payment tracks. The encouragement of flexible rates (fixed for baseline, floating for incremental volumes) introduces market-like pricing dynamics that could reward efficient hospitals while penalizing high-cost outliers.

The cross-region unification mandate is critical for national portability, ensuring that patients seeking care outside their home city face consistent grouping and payment rules. This reduces administrative friction but may force high-cost regions to align with lower-cost provincial benchmarks.

Forward-Looking Statement

Healthcare analysts expect the Dec 31, 2026, preparation deadline to trigger a wave of hospital information system upgrades and staff training investments in the fourth quarter. The March 2027 implementation date aligns with the start of China’s fiscal and planning year, ensuring full-year budget calibration under the new groups. Hospitals in advanced pilot regions—such as Zhejiang, Guangdong, and Shanghai—are likely to transition smoothly, while western provinces may face delays due to weaker IT infrastructure and smaller fund pools.

The 3.0 grouping is expected to accelerate hospital consolidation, as smaller facilities struggle to manage the data quality and coding precision required for accurate case grouping. Pharmaceutical and device manufacturers should anticipate continued downward price pressure, as the refined groups leave less room for hospitals to absorb premium product costs within standard payment bundles. The thematic disease analysis requirement (minimum five diseases annually) will create a feedback loop where high-cost therapies face heightened scrutiny, potentially influencing formulary decisions and procurement negotiations.-China Health Reform Pulse

Policy Source: https://www.nhsa.gov.cn/art/2026/9/2/art_104_21975.html?sessionid=