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  • Form Requirement: Comments must be submitted on the official feedback form (Attachment 3); both draft guidance texts are available for download alongside the notice.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

China Issues 2026–2030 Eye Health Work Plan – Cataract Surgery Rate to Top 4,000 Per Million, Universal County Cataract Services and AI‑Empowered Screening by 2030

Beijing, China – 28 Aug 2026 – The National Health Commission (NHC), the National Administration of Traditional Chinese Medicine (NATCM) and the National Disease Prevention and Control Administration (NDCP) have jointly issued the “Work Plan for Accelerating the Provision of High‑Quality and Efficient Eye Health Services (2026–2030)” (Guo Wei Yi Zheng Fa [2026] No. 22), directing provincial authorities to implement a nine‑task, full‑life‑cycle eye‑care framework that sets binding 2030 targets for cataract surgery rates, ophthalmologist density, county‑level service capability, and explicitly promotes artificial‑intelligence empowerment across screening and diagnosis.

Policy Milestone

ItemDetail
Issuing AuthoritiesNHC, NATCM, NDCP (joint)
DocumentWork Plan for Accelerating High‑Quality and Efficient Eye Health Services (2026–2030)
Document No.Guo Wei Yi Zheng Fa [2026] No. 22
Issuance Date28 Aug 2026 (proactive public disclosure)
Policy Period2026–2030 (“15th Five‑Year Plan” window)
Policy AnchorHealthy China 2030 Outline and National Health “15th Five‑Year” Plan
Guiding ApproachPrevention first, medical‑prevention integration, equal TCM/Western‑medicine emphasis, multi‑disease co‑prevention and co‑management; shift from disease‑centered to health‑centered care
RecipientsProvincial health, TCM and disease‑control authorities, incl. Xinjiang Production and Construction Corps

2030 Targets

IndicatorTarget by 2030
Refractive Screening & CorrectionSteadily higher screening rates for children aged 0–6 and primary/secondary students; eREC (effective refractive‑error coverage) continuously rising; stronger correction awareness among the elderly
Cataract Surgery Rate (CSR)>4,000 per million population; eCSC (effective cataract surgical coverage) continuously rising
Workforce>5.3 ophthalmologists (practicing/assistant) per 100,000 population; expanded optometrist ranks
County Capability>93% of county general hospitals with an ophthalmology (ENT‑ophthalmology) department; >95% of counties independently treating common eye diseases; all counties able to deliver cataract surgery; expanding basic vision‑care and low‑vision rehabilitation coverage

Nine Task Areas

  • Risk Prevention & Health Literacy: Launch the “Hundreds‑Thousands‑Tens of Thousands” eye‑health education action100 provincial‑level, 1,000 prefecture‑level, and 10,000 grassroots outreach events targeting children, the elderly, and key occupational groups, timed with National “Love Eye Day,” World Sight Day and World Glaucoma Week; integrate eye‑complication prevention into chronic‑disease management.
  • Tiered Service System: Tertiary and specialty eye hospitals handle acute, severe and complex cases; secondary hospitals manage common diseases and upward referral; township/community centers are encouraged to offer optometry and fundus photography; village clinics provide vision checks and education. Tight‑knit county medical communities and urban medical groups channel technology, remote guidance and training downward — including retired medical staff serving resource‑weak western and grassroots regions.
  • Early Screening: Strengthen newborn eye‑disease screening and vision checks for children aged 0–6 (detecting insufficient hyperopic reserve early); compile a key‑population screening catalogue covering refractive error, diabetic retinopathy, cataract and glaucoma for children, middle‑aged/elderly, and diabetes/hypertension patients; issue grassroots screening and referral guidelines.
  • Standardized Care: Revise ophthalmic diagnosis/treatment guidelines and technical norms; build specialty quality‑control indicator systems; expand day‑surgery and outpatient‑surgery categories and raise their share of elective procedures.
  • Low‑Vision Rehabilitation: Embed rehabilitation into the full care pathway; promote the “assessment–fitting–training–follow‑up” service model and build capacity in visual‑disability evaluation and assistive devices.
  • Key Disease Programs: Implement WHO’s “SPECS 2030” refractive‑care initiative; enforce myopia‑prevention guidelines with early warning for high myopia; deliver integrated TCM–Western myopia control for children; consolidate cataract blindness‑elimination gains via paired assistance, mobile medical tours and “Bright Journey” (光明行) programs; optimize care models for fundus diseases and glaucoma with AI integration, tiered diagnosis and two‑way referral with mutual result recognition; standardize eye banks and corneal‑transplant oversight; sustain blinding‑trachoma elimination; regulate retinopathy of prematurity care; build capacity in ocular trauma, strabismus/amblyopia, and rare and hereditary eye diseases.
  • TCM Synergy: Develop TCM‑specific intervention guidelines for eye health; build integrated Chinese–Western medicine “flagship” departments; extend acupuncture and acupoint‑application therapies to grassroots institutions.
  • AI & Digital Empowerment: Deep‑integrate AI, big data and 5G with eye services under the “Internet+” medical model; scale tele‑ophthalmology for remote consultation, image interpretation and follow‑up; explore medical‑AI applications in grassroots screening, assisted diagnosis, patient services, public health, research and the health industry.
  • Talent & Science: Strengthen standardized residency training and continuing education; cultivate optometrists, ophthalmic nurses and low‑vision rehabilitation specialists; conduct epidemiological surveillance of blinding diseases and their socioeconomic burden.

County Cataract Build‑Out Formula

  • Counties with resident population ≥300,000: at least one county hospital must independently perform cataract surgery, via equipment provision, personnel training and quality strengthening.
  • Counties with population <300,000: cataract surgery delivered primarily through organized mobile/visiting medical services (巡诊).

Key Metrics Defined (Official Annex)

  • eREC: Share of people receiving high‑quality refractive correction (glasses, contact lenses, or surgery) among those needing it — covering both distance and near vision.
  • eCSC: Share of people aged 50+ with good post‑operative distance vision among those needing cataract surgery; China will apply 6/12 and 6/18 dual vision standards in line with WHO flexibility guidance.
  • SPECS 2030: WHO initiative spanning Services access, Personnel capacity, Education, Cost reduction, and Surveillance.

Market Impact & Outlook

  • Surgical Volume Tailwind: The CSR >4,000 per million target, universal county cataract capability, and expanded day‑surgery categories point to sustained growth in cataract procedures, IOL implants, phacoemulsification equipment and surgical consumables through 2030.
  • Screening Infrastructure Demand: Newborn screening, fundus photography pushed down to township level, and a formal screening catalogue create procurement demand for fundus cameras, optometry equipment, and vision‑screening devices at the primary‑care tier.
  • AI Deployment Mandate: Explicit endorsement of AI in grassroots screening and assisted diagnosis — with fundus‑disease management as a named pilot area — opens a regulated pathway for AI ophthalmology diagnostic software vendors, with county and community institutions as the natural first market.
  • Refractive & Myopia‑Control Economy: SPECS 2030 implementation, eREC as a tracked indicator, and TCM‑integrated myopia programs institutionalize recurring demand across optical retail, myopia‑control products (e.g., ortho‑k, defocus lenses) and pediatric vision services.
  • Workforce as Capacity Unlock: The 5.3‑per‑100,000 ophthalmologist floor plus optometrist, nursing and rehabilitation training targets address the sector’s core bottleneck, supporting both public capacity and private ophthalmic chain expansion.

Implementation Structure

  • Health authorities at all levels lead whole‑population, whole‑life‑cycle implementation; TCM departments promote appropriate technologies and integrated care; disease‑control departments run myopia surveillance and intervention for students.
  • Provincial authorities tailor implementation measures and establish progress monitoring and evaluation mechanisms; the NHC will conduct research and guidance on plan execution as appropriate.

Forward‑Looking Statements
This brief contains forward‑looking statements regarding implementation timelines, service‑coverage targets, workforce expansion, county capability build‑out, and technology adoption under China’s 2026–2030 Eye Health Work Plan. Actual outcomes may differ due to risks including provincial execution capacity, funding allocation, training pipelines, AI regulatory approval, and evolving clinical standards.-China Health Reform Pulse

Policy Source: https://www.nhc.gov.cn/yzygj/c100068/202609/306f00c939424aadb79999b96353f36f.shtml

China Rolls Out 2026–2030 Eye Health Work Plan – Targeting Cataract Surgery Rate Above 4,000 Per Million and County‑Level Service Coverage by 2030

Beijing, China – Sep 2026 – The National Health Commission (NHC), the National Administration of Traditional Chinese Medicine (NATCM) and the National Disease Prevention and Control Administration (NDCP) have jointly issued the “Work Plan for Accelerating the Provision of High‑Quality and Efficient Eye Health Services (2026–2030)” (Guo Wei Yi Zheng Fa [2026] No. 22), a five‑year blueprint that shifts eye care from a disease‑treatment center to a health center, anchored by hard 2030 targets on cataract surgery rates, ophthalmologist density, and county‑level service capability.

Policy Milestone

ItemDetail
Issuing AuthoritiesNHC, NATCM, NDCP (joint)
DocumentWork Plan for Accelerating High‑Quality and Efficient Eye Health Services (2026–2030)
Document No.Guo Wei Yi Zheng Fa [2026] No. 22
Policy Period2026–2030 (“15th Five‑Year Plan” window)
Issuance DateAnnounced recently; exact date not disclosed in the interpretation
Guiding ApproachPrevention first, medical‑prevention integration, equal emphasis on TCM and Western medicine, multi‑disease co‑prevention and co‑management
Service ChainFull‑chain prevention–screening–diagnosis–treatment–rehabilitation, covering the entire life cycle

2030 Targets

IndicatorTarget by 2030
Refractive ScreeningSteadily rising screening rates for children aged 0–6 and primary/secondary students; stronger correction awareness among the elderly; sustained high effective refractive‑error correction coverage
Cataract Surgery Rate (CSR)>4,000 per million population; effective cataract surgery coverage continuously rising
Workforce>5.3 practicing (assistant) ophthalmologists per 100,000 population; expanded optometrist ranks
County Capability>93% of county general hospitals with an ophthalmology (ENT‑ophthalmology) department; >95% of counties independently diagnosing and treating common eye diseases; 100% of counties able to deliver cataract surgery

Nine Task Areas

  • Risk Prevention: Control modifiable risk factors to lower eye‑disease incidence.
  • Service System: Implement functional positioning of institutions and refine the prevention‑treatment service network.
  • Early Detection: Strengthen early screening for eye diseases.
  • Clinical Standards: Normalize diagnosis and treatment and lift overall service quality.
  • Rehabilitation: Improve low‑vision rehabilitation and ophthalmic rehab capacity.
  • Key Disease Management: Scientific correction of refractive errors, consolidation of cataract blindness‑elimination gains, optimized service models for diabetic retinopathy and other fundus diseases and glaucoma, and stronger prevention of other eye conditions.
  • TCM Synergy: Leverage Traditional Chinese Medicine advantages and promote integrated Chinese–Western care.
  • Digital & AI: Use information technology to empower eye health services with artificial intelligence.
  • Talent & Science: Strengthen workforce training and scientific‑technological support.

Implementation Structure

  • Lead: Health‑administration departments at all levels coordinate rollout and whole‑population, whole‑life‑cycle service management.
  • TCM Departments: Promote ophthalmic TCM‑appropriate technologies and featured therapies; drive integrated prevention and treatment.
  • Disease‑Control Departments: Conduct routine surveillance and intervention on myopia and other common student diseases and their risk factors.
  • Provincial Execution: Provincial health authorities tailor supporting measures to local conditions and establish monitoring and evaluation mechanisms to ensure tasks land in detail.

Market Impact & Outlook

  • Volume Tailwind for Ophthalmology Services: A CSR push above 4,000 per million — from an already substantial base — plus mandated county‑level cataract surgery capability signals sustained growth in surgical volumes, IOL implants, and ophthalmic equipment demand through 2030.
  • Screening Economy: Rising refractive‑screening coverage for children and students institutionalizes a recurring, population‑scale screening funnel, benefiting optical chains, myopia‑control products, and vision‑care providers nationwide.
  • Workforce Expansion as Capacity Unlock: The 5.3‑per‑100,000 ophthalmologist floor and optometrist build‑out address the sector’s core bottleneck, easing constraints on both public hospital eye departments and private expansion.
  • AI Integration Mandate: Explicit endorsement of AI empowerment opens deployment pathways for AI‑assisted fundus screening and diagnostics — a category already piloted in China’s primary‑care network — with county‑level screening needs as the natural first market.
  • Policy Continuity: Building on programs dating to the 1980s and “14th Five‑Year” gains, the plan’s multi‑department, monitored implementation framework makes target slippage visible — and sector budgeting more predictable.

Forward‑Looking Statements
This brief contains forward‑looking statements regarding implementation timelines, service‑coverage targets, workforce expansion, and technology adoption under China’s 2026–2030 Eye Health Work Plan. Actual outcomes may differ due to risks including provincial execution capacity, funding allocation, workforce training pipelines, and evolving clinical‑technology standards.-China Health Reform Pulse

Policy Source: https://www.nhc.gov.cn/yzygj/c100067/202609/13cb984a2d2f4c4383d97b78c3a2b7ea.shtml