Abstract

China’s volume-based procurement (VBP) programme for medical devices represents one of the most structurally significant regulatory and commercial interventions in global medical technology (MedTech) since the introduction of the EU Medical Device Regulation. Launched nationally for medical devices in 2019 and expanded through five national tender rounds as of 2025, VBP has driven price reductions of 60−96% across major device categories and fundamentally reordered competitive dynamics between global corporations and domestic Chinese manufacturers.

This article examines the regulatory framework underpinning VBP, including:

• The compounding effect of VBP on the Diagnosis Related Group and Diagnosis Intervention Packet (DRG/DIP) payment reform framework
• The intersection between VBP and China’s ‘Made in China 2025’ industrial policy
• The simultaneous healthcare anti-corruption campaign
• The category-specific impact on foreign manufacturers across implants, capital equipment and in vitro diagnostics
• The escalating international trade response from both the EU and the US
• Strategic options for foreign manufacturers, including the innovation exemption pathway, real-world evidence programmes and localisation strategies

Each section concludes with an assessment of the practical implications for regulatory affairs teams, covering portfolio management, evidence generation, innovation designation and localisation planning.

The article concludes that VBP is a permanent structural feature of the Chinese market and that manufacturers with significant Chinese exposure must integrate regulatory, commercial and geopolitical risk assessment into a unified market access strategy.