China’s legislature approved the Healthcare Security Law on August 28, 2026, and it will come into effect at the start of 2027. The law formally brings medical devices and consumables into the national insurance coverage system alongside drugs. Until now, medical device coverage relied mostly on agency documents such as reimbursement catalogs, pricing guidelines, etc., that could shift over time. Now the principle that devices belong in the insurance system is written into national law, which gives companies a more stable foundation. However, being eligible for coverage will not guarantee a listing, because which products get covered and at what prices will still be decided on a case-by-case basis. Pricing decisions will now, more than before, also need to weigh clinical value and cost-effectiveness. Manufacturers will likely need data gathered in China, comparative cost studies, and real-world evidence to justify their prices.
The law also gives legal backing to bundled, case-based, and outcome-based payment models. These could help high-tech products that tend to be underpaid under the current per-service billing. In addition, hospitals and pharmacies must now use electronic tracking for devices, so gaps in a company’s UDI data or labeling could get in the way of hospital purchasing and insurance payments.
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.