China

The National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), is the primary regulatory authority responsible for overseeing the safety, efficacy, and quality of medical devices, diagnostics, pharmaceuticals, and digital health products in China. The principal governing legislation includes the Drug Administration Law (revised 2019), the Regulations on the Supervision and Administration of Medical Devices (revised 2021), and a series of NMPA-issued guidance documents. Pharmaceutical products are classified and reviewed based on innovation level (Class 1 through Class 5.2 for chemical drugs), while medical devices are tiered into three risk-based classes (Class I, II, and III), with Class III requiring the most rigorous pre-market approval. Digital health software and AI-based diagnostic tools are increasingly regulated under the medical device framework when they meet criteria for clinical decision support.

Key submission requirements include the filing of a Common Technical Document (CTD)-aligned dossier for pharmaceuticals, with China-specific module requirements for local clinical data. For many years, China mandated locally conducted clinical trials for imported products, but landmark reforms under the 2017 and 2018 NMPA restructuring and the "Opinions on Deepening the Reform of the Review and Approval System" now allow greater acceptance of overseas multi-regional clinical trial (MRCT) data, accelerating access for innovative products. Foreign manufacturers must appoint a China-based legal agent or local authorized representative to act as the regulatory liaison. Expedited pathways, including Priority Review, Breakthrough Therapy Designation, and Conditional Approval, are available for products addressing unmet clinical needs. Domestic registration of medical devices also requires compliance with the Chinese national standards (YY standards) and, for Class II and III devices, submission to the NMPA Center for Medical Device Evaluation (CMDE).

Public procurement of health products in China operates through a centralized and highly coordinated system. The National Healthcare Security Administration (NHSA), established in 2018, oversees national reimbursement policy and drug pricing, while the National Health Commission (NHC) sets clinical standards and public hospital policy. A defining feature of the Chinese procurement landscape is the National Centralized Drug Procurement (NCDP) program, commonly known as "volume-based procurement" (VBP) or "4+7" procurement, administered by the Joint Procurement Office under the NHSA. This system uses competitive tendering to secure large-volume purchase commitments from public hospitals in exchange for significant price reductions, typically 50-90% below pre-tender prices. Medical devices and diagnostics are increasingly included in centralized procurement rounds, following the success of drug-focused rounds. Provincial and municipal health commissions also conduct their own supplementary tenders for products not covered under national rounds, creating a two-tiered public procurement structure at the national and sub-national levels. Inclusion on the National Reimbursement Drug List (NRDL) or the medical device procurement catalogues is a prerequisite for meaningful access to the public hospital channel, which dominates healthcare delivery in China.

The private sector channel, including private hospitals, retail pharmacies, and clinic networks, represents a growing but secondary procurement pathway, particularly for premium-priced innovative products not yet included in national reimbursement or VBP programs. International donor and multilateral procurement channels, such as those operated by UNICEF, the Global Fund, USAID, or Gavi, play a minimal role in China given its upper-middle-income country status; China is more commonly a product supplier to such programs than a recipient. However, domestic manufacturing preference is a strong and explicit policy priority: the "Made in China 2025" strategy and the "Healthy China 2030" plan both incentivize local production of medical devices, active pharmaceutical ingredients (APIs), and health technology. Import substitution policies, preferential procurement scoring for domestically manufactured products, and government support for local champions create a challenging environment for foreign manufacturers competing on cost in the public tender system. Multinational companies are increasingly encouraged to establish local manufacturing or joint venture arrangements to remain competitive in public procurement channels.