Imported medical devices still require NMPA registration by risk class (I/II/III), and Class II/III overseas manufacturers must register their production sites with the NMPA before any China market entry. 进口医疗器械仍须按风险分类（一/二/三类）取得国家药监局注册；二类、三类境外生产企业须向 NMPA 登记生产场地后方可进入中国。 Volume-Based Procurement has expanded from high-value implants into … Medical-device import registration and the foreign-device strategy under domestic substitution (2026)Read more
行业洞察 / Industry Insights
China’s innovative-drug market and the foreign-pharma China playbook (2026)
China’s innovative-drug market is projected to exceed ¥1.3 trillion in 2026, with 2025 out-licensing deals reaching roughly US$135 billion and the first quarter of 2026 alone surpassing US$60 billion. 2026 年中国创新药市场规模预计突破 1.3 万亿元；2025 年对外授权交易总额约 1357 亿美元，2026 年一季度即突破 600 亿美元。 The … China’s innovative-drug market and the foreign-pharma China playbook (2026)Read more