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2026-08-12 00:00 China Policy & Regulation Industrial Planning Translated from ZH

Zhejiang Cuts BCI Device Review to 40 Days

Summary The General Office of China's Zhejiang Provincial People's Government issued Several Measures for Promoting Industry-University-Research Coordination in Brain-Computer Interfaces, document number Zhe Zheng Ban Fa [2026] No. 33, dated July 16, 2026 and released on August 12, comprising 18 measures in five areas. Class II BCI devices of clear clinical value may enter a special review procedure with the timeline cut to within 40 working days, while medical consumables are listed through a green channel within 10 working days. Funding comes in four tiers: up to 10 million yuan for a provincial major science and technology project, up to 8 million yuan for research hospitals deeply involved in preclinical work and product launch, up to 3 million yuan for applied basic research, and 1 million, 500,000 and 100,000 yuan for leading international, national and local standards. Beds used solely for clinical research are exempt from efficiency and DRG performance assessment.
Why it matters Forty working days is the shortest Class II device review pledge from any province, less than half the 90 days Shandong promised nine days earlier, marking review speed as a new axis of inter-provincial competition. The 8 million yuan tier goes to research hospitals rather than companies and pairs with an exemption of research beds from performance assessment, addressing why hospitals are reluctant to give up capacity.

BCIwiki (bciwiki.com) — The General Office of China's Zhejiang Provincial People's Government (浙江省人民政府办公厅) issued Several Measures for Promoting Industry-University-Research Coordination in Brain-Computer Interfaces under document number Zhe Zheng Ban Fa [2026] No. 33, with the regulatory document number ZJSP01-2026-0010, dated July 16, 2026 and publicly released on August 12, 2026. The text contains 18 measures across five areas.

On regulatory review, Class II BCI devices with clear clinical value and strong innovation may enter a special review procedure with the timeline cut to within 40 working days. Products in the special review channel for innovative devices run by China's National Medical Products Administration receive dedicated case teams, urgently needed devices get immediate handling for registration testing and inspections, and medical consumables are listed through a green channel within 10 working days of application. On funding, a provincial major science and technology project may receive up to 10 million yuan, a research hospital deeply involved in preclinical work and product launch up to 8 million yuan per project, an applied basic research project up to 3 million yuan, and bodies leading international, national or significant local standards up to 1 million, 500,000 and 100,000 yuan per standard respectively.

For clinical work the measures call for BCI trial bases, clinical and translational wards and pre-enrolment cohorts, and exempt beds used solely for clinical research from assessments of bed efficiency, turnover, occupancy and diagnosis-related group performance. On payment, inpatient cases using listed and qualifying BCI products may be rewarded under rules for innovative medical technology reimbursement, and qualifying products are to be covered by work injury insurance. The industrial layout centres on Hangzhou and is supported by Ningbo for new materials, Wenzhou for clinical demonstration, Jiaxing for key components and Shaoxing for advanced chip manufacturing and packaging. By 2027 the province aims to develop more than five representative products in verified use and to lift BCI industry revenue above 5 billion yuan.

Compiled by BCIwiki from public sources

General Office of the Zhejiang Provincial People's Government timeline

2026-09 Zhejiang, First to Reimburse BCI Fees, Cuts Device Review to 40 Days All entries →
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