With countries around the world in the grip of the Covid-19 pandemic, demand for test kits and protective clothing and equipment has soared, leading to a rush of Chinese medical supply exports, by firms not licensed to sell them on their domestic market.

Rogue Chinese manufacturers are exploiting loopholes in regulatory processes, as they race to meet the explosion in demand to combat the pandemic, including adapting product descriptions and speeding up testing procedures.

Chinese authorities originally eased export processes on medical equipment in March after officials asserted the pandemic was slowing, releasing products originally destined for the domestic market, prompting factories to look overseas, where there has been an acute shortage of medical equipment.

Unscrupulous Chinese factories, eager to cash in, have been cutting corners where they can, including manufacturers with no relevant experience joining in.

According to the FT, almost a fifth of China’s mask factories only began operating after January, ranging from apparel factories to electronics makers.

Responding to European complaints of being sold substandard products, China has banned the export of test kits and other medical supplies by firms not licensed to sell them in China.

Only companies approved by the National Medical Products Administration will be permitted to export their products overseas.

In an announcement today, on the orderly export of medical supplies, the Ministry of Commerce and the General Administration of Customs, introduced the new procedure for the export of Medical products, including the requirement for the shipper to provide a valid medical device product registration certificate.

The medical products affected include COVID-19 test kits, surgical mask, medical protective clothing, breathing ventilator, infrared thermometers, temperature guns, exporters must provide registered certificates during customs clearance.

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This LINK will take you to the official notice – which is translated below for reference only.

Announcement of the Ministry of Commerce and the General Administration of Customs on the orderly export of medical supplies

Announcement No. 5 of 2020

At present, the global epidemic situation is accelerating. On the basis of doing a good job of preventing and controlling the epidemic, the orderly export of medical supplies is an important measure to deepen international cooperation in the prevention and control of the epidemic and jointly respond to the global public health crisis.

In the special period of epidemic prevention and control, in order to effectively support the global fight against the epidemic, ensure product quality and safety, and regulate the export order, starting April 1, export of new coronavirus detection reagents, medical masks, medical protective clothing, ventilator, infrared thermometers, etc.

When the enterprise declares to the customs, it must provide a written or electronic declaration (see Annex 1 for the template), and promise that the export products have obtained China’s medical device product registration certificate (for relevant registration information, see Annex 2), which meets the quality standards of the importing country (region).

The customs shall inspect and release the medical device product registration certificate approved by the drug regulatory department. The above-mentioned quality supervision measures for the export of medical supplies will be adjusted dynamically according to the development of the epidemic situation.

Relevant medical material export enterprises shall ensure product quality and safety, meet relevant standards and requirements, and actively support the international community in fighting the epidemic.

Ministry of Commerce General Administration of Customs State Drug Administration March 31, 2020

Annex: 1. Template for declaration of medical supplies for export
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2. China’s relevant medical device product registration information (dynamic update of the website of the State Drug Administration www.nmpa.gov.cn)
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