In China, a newly registered medical device usually waits one to two years before hospitals can bill for it under insurance. Much of that delay comes from creating a medical service price item, which only begins after product approval. A pilot launched by the National Healthcare Security Administration (NHSA) on September 15, 2026, moves this insurance step ahead of approval, so pricing can be settled shortly after registration.
Under the pilot, a leading tertiary hospital files a request with its provincial healthcare security bureau, and the bureau issues a preliminary pricing opinion before the product is approved. One filing covers all hospitals. The pilot applies to new technologies, equipment, and consumables that meet major clinical needs. It excludes incremental upgrades, products that can be billed as standard consumables, and most diagnostic reagents.
Once approved, a product can receive one of three outcomes. If no existing price item covers the product/service, it can get a fast-tracked new price, which other provinces can then adopt. If its clinical value or cost-effectiveness is still unproven, it can get a conditional price, which lets a few hospitals charge for the product/service while the company gathers real-world evidence. Otherwise, it can be billed under an existing price item that already covers the product/service.
Companies must justify the price when consumables or equipment make up more than 60% of an item’s price, or when a single consumable costs more than 5,000 RMB (750.63 USD). The NHSA encourages manufacturers to start real-world value studies early in the development process.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.