China Enacts First Healthcare Security Law: Impact on Global Medtech

On August 28, 2026, the Standing Committee of the National People’s Congress passed the Healthcare Security Law of the People’s Republic of China. The law will take effect on January 1, 2027, establishing a statutory framework for medical insurance reimbursement, health economic evaluation, payment mechanisms, and healthcare product traceability.

For international medical device and in-vitro diagnostic (IVD) manufacturers, four provisions are particularly relevant to market access:

• Article 23: Pharmaceuticals and medical devices are expressly addressed within the statutory framework for medical insurance reimbursement.
• Article 24: Evidence-based medicine and health economic evaluation are incorporated into decisions concerning the medical insurance catalog, pricing, and reimbursement.
• Article 26: Diversified and composite payment mechanisms receive a statutory basis.
• Article 34: Digital traceability requirements for medical devices and drugs are incorporated into the legal framework.

The practical impact will depend on how these provisions are translated into national and regional implementation rules, catalog decisions, pricing policies, and payment mechanisms. 

Article 23 Gives Medical Device Reimbursement a Statutory Basis

Article 23 explicitly places medical devices and medical consumables alongside pharmaceuticals within the statutory framework for determining medical insurance reimbursement eligibility.

Previously, medical device coverage was governed primarily by administrative guidelines and departmental notices issued by the National Healthcare Security Administration and regional authorities. By codifying medical consumables in primary legislation, the National People’s Congress provides a clearer and more durable legal basis for device reimbursement.

However, statutory eligibility does not mean automatic reimbursement. Article 23 establishes the legal basis for including medical devices in the reimbursement system, but does not determine which products will be listed, at what price, or under which payment mechanism.

Therefore, manufacturers should consider the following when evaluating their medical device portfolios:

• Is the product within the statutory reimbursement framework?
• Can the product satisfy applicable evaluation and catalog requirements?
• Can the product secure an economically supportable price and payment arrangement?

Article 24 Increases the Importance of Health Economic Evidence

Article 24 incorporates evidence-based medicine and health economic evaluation into the statutory framework for medical insurance catalog adjustments, pricing benchmarks, and reimbursement decisions.

This extends evidence requirements beyond those typically assembled for regulatory registration. A device may demonstrate safety, performance, and clinical efficacy while still facing questions such as:

• What incremental clinical benefit does it provide compared with existing alternatives?
• What additional healthcare resources does it require?
• Does the clinical benefit justify the proposed price?
• What is the budget impact of broader adoption?
• Is there sufficient evidence from the Chinese healthcare environment to support the assessment?

Manufacturers should address these questions before reimbursement negotiations begin. Local clinical data, comparative cost-effectiveness analyses, and real-world evidence will be increasingly important for supporting price points and securing placement on national and provincial reimbursement lists.

Article 26 Creates a Framework for Diversified Payment Models

Article 26 formalizes the support and expansion of diversified, composite payment mechanisms, authorizing bundled, case-based, and value-oriented reimbursement strategies.

For international companies introducing innovative, technology-intensive products, these flexible payment channels offer an alternative to traditional fee-for-service models that often undervalue advanced medtech. Value-based payment models allow manufacturers to negotiate coverage based on long-term clinical outcomes and overall hospital efficiency.

However, while Article 26 establishes the high-level legal architecture, the practical commercial advantages will depend entirely on how regional health authority implementing rules, price setting, and local hospital budget allocations are executed leading up to 2027.

Article 34 Makes Digital Traceability a Statutory Compliance Issue

Article 34 brings digital traceability for pharmaceuticals and medical devices into the national legal framework, requiring designated medical institutions and pharmacies to comply with the applicable traceability system.

This elevates product identification and traceability from an operational consideration to a core market-access and compliance requirement. Where procurement, reimbursement, and settlement processes rely on traceability data, products that cannot be properly identified or tracked could face barriers to hospital purchasing and public-fund settlement.

Manufacturers, importers, and distributors should therefore evaluate their existing Unique Device Identification data structures, packaging label specifications, and downstream distributor tracking systems. Supply-chain readiness is now as fundamental to market access as securing a registration certificate.

What International Medtech Companies Should Do Now

To maintain commercial momentum before the law takes effect on January 1, 2027, international medtech businesses should consider several actions:

• Audit current product portfolios against local medical insurance catalog criteria and determine whether public reimbursement aligns with target positioning.
• Build robust health economics evidence by designing post-market clinical studies and comparative cost-effectiveness models tailored to China's clinical environment.
• Review digital traceability infrastructure by auditing internal UDI database mapping, packaging labeling, and distributor reporting capabilities.

As implementation details continue to emerge at national and provincial levels, companies must actively monitor shifting regulatory developments. This is a process best navigated alongside local regulatory experts, like Cisema, who can interpret how evolving catalog revisions, payment pilots, and enforcement rules directly impact product registration and ongoing market access.

Final Thoughts: Navigating the 2027 Regulatory Shift

The Healthcare Security Law gives medical devices a clearer place within China’s reimbursement system, while increasing the importance of health economic evidence, payment strategy, and digital traceability. For international manufacturers, the priority now is to assess where these changes could affect individual products and address gaps before implementation begins on January 1, 2027.

Navigating this evolving landscape requires both regulatory precision and strategic market access planning. Cisema provides end-to-end support to help international manufacturers assess the impact of the Healthcare Security Law on their product portfolios, from evaluating health economic requirements and optimizing Regulatory Affairs strategies to implementing digital UDI traceability systems and monitoring local policy developments.

To evaluate your market access strategy and ensure your products are fully prepared for China's 2027 regulatory environment, contact Cisema today.

Further Information

• Learn more about Cisema’s services for medical device registration in China.
• Explore Cisema’s pharmaceutical consulting services.

References

• ‍China Has Introduced a Special Law on Healthcare Security, Effective From January 1 Next Year (我国对医疗保障出台专门法律，自明年1月1日起施行),
• Healthcare Security Law of the People's Republic of China (中华人民共和国医疗保障法), adopted at the 24th Meeting of the Standing Committee of the 14th National People's Congress on August 28, 2026.