China impose strict medical export controls
Following complaints from disgruntled governments, Chinese manufacturers of coronavirus test kits and related medical supplies have been told they can no longer export their products unless they are already licensed to sell the product in China.
The move comes after China was hit with a number of complaints from buyers in Europe about the quality and accuracy of tests kits and other products and a day after the Financial Times (FT) reported that concerns about the quality of Chinese-made equipment had led authorities in Spain, the Netherlands and Turkey to reject masks and tests as substandard.
Chinese authorities originally eased export processes on medical equipment in March after officials asserted the pandemic in China 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.
We are sourcing, export clearing and shipping China and US medical exports, including PPE and breathing equipment for public and private clients
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 the European complaints, 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.
This LINK will take you to the official notice.
We provide a translation of the notice below to guide you through the new requirements.
The new rule applies to all companies seeking to export test kits, face masks, protective clothing, ventilators and infrared thermometers, according to a joint statement issued by the Ministry of Commerce, General Administration of Customs and the National Medical Products Administration.
Exporters must provide registered certificates during customs clearance. Previously, Chinese exporters were required only to have CE certification to indicate their goods conformed to the health and safety standards required for sale within the European Economic Area.
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 from China
2. China’s relevant medical device product registration information (dynamic update of the website of the State Drug Administration www.nmpa.gov.cn)