What is The China Medical Device Exportation Whitelist?
With the global spread of 2019 novel coronavirus (COVID-19), many countries are facing the shortage of medical equipment including PPE, COVID-19 diagnosis reagent kits, and ventilators. Many manufacturers in China rushed to build their production lines for medical equipment, however, the quality issues and complaints were reported in many regions.
Following a short period of exportation restriction, on April 25, 2020, China’s Ministry of Commerce (MOFCOM), the General Administration of Customs (GACC), and the State Administration for Market Regulation (SAMR) jointly issued the Announcement NO.12 of 2020 of Ministry of Commerce, General Administration of Customs and State Administration for Market Regulation on Reinforcing Quality Regulation on Exported Supplies for COVID-19 Response. This statement revised a previous policy that allows only National Medical Product Administration (NMPA, or commonly known as CFDA) certified medical equipment to export. The new statement allows medical devices to be exported as long as they are registered with certificates in destination countries, such as FDA Emergency Use Authorization (EUA) or CE certificates. Chinese authorities also ordered exporters must submit an electronic or written declaration for customs clearance to commit that their products meet the quality standards and safety requirements of the importing country or region. GACC will inspect and release the exports according to the list of manufacturers with foreign standard certification or registration provided by MOFCOM, which is known as the “China Medical Device Exportation Whitelist”.
Where Can I Find the Whitelist?
The MOFCOM whitelist is updated and published on the website of CHINA CHAMBER OF COMMERCE FOR IMPORT&EXPORT OF MEDICINES &HEALTH PRODUCTS (CCCM-HPIE). Customs must confirm whether the manufacturer is on the China medical device exportation whitelist, before releasing the exports.
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