Reacting to concerns raised by western countries about the quality of some medical products, Chinese authorities said last week that destination quality certification is no longer acceptable and that only those manufacturers with accreditation to sell their products within China will be allowed to export test kits, surgical masks, protective gowns, ventilators and infrared thermometers.
Trade groups representing medical device manufacturers, have petitioned their local governments and customs agencies to allow them to ship their products, many of which are now stockpiled in factories and at ports – to the places where they are most needed.
News sources suggest it will take companies between three and six months to get a licence to sell medical products in China, restricting their ability to get essential supplies to those places where there is an immediate need.
Chinese factories have working around the clock to meet the global demand for medical equipment, with more than 15,500 firms installing production lines for face masks in response to the spread of Covid-19 outbreak, pushing the country’s daily output to 160 million.
From 1st April only those companies approved by the National Medical Products Administration will be permitted to export their products overseas.
As the coronavirus began to spread within China, Beijing granted 23 local test kit manufacturers special licences to sell their goods at home. Under the new restrictions, those firms can now sell their products overseas, while those with European or US certification, but not a local licence, no longer can.
Foreign buyers are racing to source sufficient stocks from approved Chinese suppliers.
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.
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 LINK
Annex 2. China’s relevant medical device product registration information (dynamic update of the website of the State Drug Administration www.nmpa.gov.cn) LINK