New Compliance Requirements for the Export of Medical Devices from China to abroad

China is currently one of the most important exporting nations of medical devices, including devices essential to treating COVID-19 patients and keeping healthcare professionals safe. China has now strengthened its export requirements for the export of medical devices. Foreign companies should be aware that from 1 April 2020 the Chinese exporter must provide a declaration to the Chinese customs office, that the medical devices to be exported are duly registered at the Chinese National Medical Product Administration (“NMPA”). This new requirement was released on 31 March 2020 by China’s Ministry of Commerce, the NMPA and the General Administration of Customs (“GACC”) in the jointly issued No. 5 Announcement of 2020 (“Announcement”). The Announcement covers testing kits, medical face masks, medical protective suits, ventilators and infrared thermometers. Previously, all that was required was that the medical devices satisfied the quality-control standards of the export destination. The Announcement provides a template declaration and a list of registered manufacturers with the NMPA (the list is accessible on the website of NMPA and updated from time to time). Chinese Customs will release the exports based on the registration certificates issued by NMPA.

For exported medical devices that are mixed with imitation, fake or substandard products, the Customs authorities will prevent the export, confiscate any illegal gains and impose a fine of between 50% and 300% of the value of the products, in accordance with China’s Import and Export Commodity Inspection Law. In addition, the exporter may face criminal liability for smuggling and of course potential fraud claims from the buyer of the medical devices.

Any violations of the new requirements in the Announcement can also affect the credit status of the exporter. If the violation constitutes a smuggling act or a smuggling crime, the Customs authorities will reduce the exporter’s credit rating to that of an “untrustworthy enterprise”. Chinese authorities will likely inspect much more strictly whether the medical devices to be exported comply with the new requirements under the Announcement. Meanwhile, the GACC and relevant state departments can impose joint sanctions on the exporting company, increasing the exposure of any violations and they will also publish details concerning punished companies on the official website of GACC and other credit websites.