Medical supplies sent overseas must prove they meet countries’ standards

China has adopted new measures to ensure the quality of medical supply exports such as COVID-19 test kits and surgical masks, which are expected to offer more robust guarantees on these products, experts said on Wednesday.

Starting on Wednesday, exporters of COVID-19 test kits, surgical masks, protective gowns, ventilators and infrared thermometers must provide extra documentation when they go through customs clearance, in order to prove their products have obtained China’s registration certification for medical devices and met the quality standards of the importing country or region, an official document said.

The customs authorities will release the exports based on a registration certificate approved by medical product administrations, said the document, which was jointly released by the Ministry of Commerce, the General Administration of Customs and the National Medical Products Administration.

Zhang Yan, CEO of Willingmed, a Beijing-based a diagnostics firm, said the government’s new regulation will further ensure product quality.

“Although certificates from the National Medical Products Administration have no legal effect overseas, the certificates are trustworthy across the world as the administration has a strict review process to register drugs and medical equipment. Some Southeast Asian countries even take the administration’s certificate as their own import license,” he said.

Chen Qiaoshan, a medical analyst at Beijing-based market research consultancy Analysys, said by offering a higher threshold of registration, the Chinese government has strengthened supervision and control of exported medical drugs and equipment.

China accounts for about one-fifth of the global production of multifunction ventilators and for about 50 percent of global face mask output.

To meet soaring overseas demand for ventilators, manufacturers in China have been working overtime, said Xu Kemin, an official with the Ministry of Industry and Information Technology.

Eight of China’s 21 multifunction ventilator makers have obtained the European Union’s compulsory CE quality mark, Xu said at a recent news conference.

Foreign Ministry spokeswoman Hua Chunying said on Wednesday that it is true that anti-epidemic materials involve detailed issues such as the different recognition standards in different countries and regions. “But such issues should not become barriers for cooperation on anti-epidemic materials,” Hua said.

Mo Jingxi contributed to this story.

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