The National Healthcare Security Administration (NHSA) issued the “Notice on Piloting the Pre-Project Approval System for Medical Service Price Items for High-Level Novel Technologies and Products” (the “Notice”), advancing the acceptance point for medical service pricing project approval through a new pre-project approval system. Under the policy, provincial healthcare security departments will intervene in advance with pricing policy guidance, preparing rapid project approval once novel technologies and products win regulatory clearance — achieving seamless connection between approval for application and pricing project approval and accelerating the clinical application of major innovative achievements.
Policy Snapshot
| Item | Detail |
|---|---|
| Issuing Authority | National Healthcare Security Administration (NHSA), China |
| Document | Notice on Piloting the Pre-Project Approval System for Medical Service Price Items for High-Level Novel Technologies and Products |
| Core Mechanism | Advance provincial-level intervention with pricing guidance before products receive application approval |
| Policy Goal | Seamless connection between approval for application and pricing project approval; accelerated clinical adoption of major innovations |
| Issuance Date | 15 September 2026 (recently issued) |
| Implementation Level | Provincial healthcare security departments |
Scope of the Pre-Project Approval System
Eligible categories:
- Novel technologies with significant clinical value and breakthrough diagnostic and therapeutic approaches.
- Novel equipment that meets major clinical needs, effectively addresses diagnostic and therapeutic challenges in key areas, and improves efficiency and precision.
- Novel consumables that fill diagnostic and therapeutic gaps, focus on patient benefit, and change surgical protocols.
Excluded from scope:
- Products suitable for charging as drugs or medical consumables that do not require supporting pricing project approval.
- Iterative upgrades based on existing medical consumables or equipment.
- Diagnostic reagents other than the three categories of novel reagents that meet the diagnostic and therapeutic needs of major diseases.
Declaration Procedure – One Hospital Leads, No Duplicates
- Lead Applicant: Pre-project approval shall be declared by one tertiary hospital taking the lead, directly to the provincial healthcare security department, which issues a pre-project approval conclusion in accordance with procedures.
- No Repeat Filing: After the first hospital declares the same technology or product, other medical institutions are not required to repeat the declaration, and provincial departments shall not accept duplicate applications.
Transformation Mechanisms – Three Pathways After Product Approval
Once the novel technology or product is formally approved for application, the provincial department that accepted the pre-project approval efficiently advances transformation of the outcomes through one of three methods:
| Pathway | Trigger Condition | Mechanism |
|---|---|---|
| ① Addition of Price Items | Existing price items cannot cover the related medical services | Rapid addition via a green channel; other provinces may quickly follow — forming “approval in one province, follow-up nationwide” |
| ② Conditional Addition | Clinical value or cost-effectiveness remains to be verified | Conditional price items allowing a small number of regional institutions to charge; applicant must complete real-world comprehensive medical insurance value evaluation within a committed time limit, followed by transfer, price reduction, or termination based on results |
| ③ Price Item Compatibility | Existing price items can cover the related medical services | Clinical charging demands met through price item compatibility; other provinces may quickly refer to and handle accordingly |
Price Monitoring & Cost Transparency Rules
- Consumable Price Guidance: In carrying out pre-project approval work, provincial departments shall simultaneously focus on prices of related medical consumables and guide reasonable pricing.
- 60% Cost Threshold: Where medical equipment depreciation or consumable costs exceed 60% of the price composition of a new item, explanations of price reasonableness and cost-effectiveness must be provided.
- RMB 5,000 Consumable Threshold: Where the price of a medical consumable exceeds RMB 5,000, the same explanations apply, together with reporting of ex-factory prices and price composition information.
Real-World Value Evaluation – Encouraged From Day One
- Early Embedding: Applicants are encouraged to embed real-world comprehensive medical insurance value evaluation plans synchronously during stages such as technology concept validation, laboratory products, and clinical research.
- Decision Reference: Evaluation results shall serve as reference for decisions on transfer and price adjustment of medical service price items — effectively building evidence generation into the pricing lifecycle.
Industry Impact & Outlook
- Speed-to-Market: By shifting pricing preparation upstream of product approval, the pilot addresses a long-standing bottleneck in which innovative devices and technologies waited months or longer for a chargeable price item after market clearance.
- National Synergy: The “approval in one province, follow-up nationwide” design could compress multi-province pricing rollout for breakthrough products.
- Evidence-Linked Pricing: Conditional addition with mandated real-world evaluation introduces an explicit value-verification pathway — with transfer, price reduction, or termination as possible outcomes — aligning reimbursement with demonstrated cost-effectiveness.
- Cost Discipline: The 60% cost-composition and RMB 5,000 consumable thresholds signal continued scrutiny of device depreciation and high-value consumable pricing within new service items.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding implementation of the NHSA pre-project approval pilot, provincial pricing actions, and clinical adoption of novel technologies. Actual outcomes may differ due to risks including provincial execution practices, subsequent regulatory amendments, real-world evaluation results, and enterprise pricing and compliance decisions.-Fineline Info & Tech
