Xiamen launches whitelist to streamline biomedical imports

The Xiamen Biomedical Pilot and Industrialization Base. [Photo provided to chinadaily.com.cn]

Fujian province has approved its first whitelist for biomedical imports, allowing qualified companies to streamline customs procedures for special biological materials.

A 20-liter batch of blood reference material from Switzerland, which arrived at the Xiamen Biomedical Pilot and Industrialization Base on July 8, was put into research and production following on-site supervision by Xiamen Customs, marking the first implementation of the province's biomedical import whitelist.

The materials, imported by Xiamen Wantai Kerry Biotechnology, are key raw materials for producing in vitro diagnostic reagents. The research and production of diagnostic reagents rely heavily on imported materials such as blood and cells, which require supervision from multiple authorities due to their biological safety risks.

Previously, companies had to submit separate applications to different authorities for each import shipment, resulting in lengthy approval procedures.

To address this, Xiamen's science and technology authorities, together with customs, commerce, health, and other departments, introduced a joint supervision mechanism for imported and exported special items. Under the mechanism, companies included on the whitelist undergo a single comprehensive assessment covering the research, production, transportation, storage, use, and waste disposal of special materials.

After approval, companies can make one application, receive one assessment, and complete multiple shipments under the same approval, significantly reducing customs clearance time.

Xiamen now has more than 1,900 biomedical companies, with the industry valued at over 100 billion yuan ($14.75 billion). The city's medical devices, including diagnostic reagents, account for more than 80 percent of Fujian's total.

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