(May 13, 2020) On April 25, 2020, China’s Ministry of Commerce (MOFCOM), the General Administration of Customs (Customs), and the State Administration for Market Regulation (SAMR) jointly issued the Announcement on Further Strengthening Quality Oversight for Exported Pandemic Prevention and Control Supplies (English translation). The announcement eases a previous restriction that required medical supplies needed for pandemic control—COVID-19 testing kits, medical masks, personal protective equipment, ventilators, and infrared thermometers—to obtain Chinese medical device registration certifications before being exported. Effective April 26, 2020, the specified pandemic control supplies can be exported if they have obtained foreign certifications or registrations that are accepted by the importing countries.
Previously, following foreign complaints—mainly from European countries—that some Chinese virus test kits, masks, and other products did not meet quality standards, Chinese authorities ordered that exporters of the specified pandemic control supplies must provide a declaration certifying that their products had been duly registered in China and conformed to the importing country’s quality standards. (MOFCOM, Customs, and National Medical Products Administration, Announcement on Orderly Operation of Medical Supply Export Business, Mar. 31, 2020, effective Apr. 1, 2020.) Under this announcement, Chinese Customs must verify the products’ Chinese medical device registration certifications before releasing the exports.
The March 31 announcement was followed by a Customs announcement issued on April 10, 2020, that subjected 11 types of medical supplies—medical masks, medical protective suits, infrared thermometers, ventilators, surgical caps, medical goggles, medical gloves, medical shoe covers, patient monitors, medical disinfection wipes, and medical disinfectants—to statutory inspection.
According to the South China Morning Post, some suppliers had complained that the requirement of Chinese certifications effectively banned them from selling their products abroad because the process of obtaining the Chinese certifications could be complicated and time-consuming. It was also reported that the export restrictions had led to delays in shipping cargo because of confusion among manufacturers and traders over how to comply with the requirement.
According to the April 25 announcement, the MOFCOM would provide a list of medical device and supplies companies that have been confirmed by the MOFCOM to have obtained foreign certifications or registrations (“MOFCOM white list”). The MOFCOM white list is published and updated on the website of the China Chamber of Commerce for Import and Export of Medicines and Health Products. Before releasing the exports, Customs is required to verify if the manufacturer is on the MOFCOM white list.
The new announcement also requires that non-medical masks for export meet either Chinese or foreign standards. MOFCOM maintains another white list of non-medical masks manufacturers that have obtained foreign authentications or registrations. Non-medical masks that the SAMR has found to be substandard are prohibited for export. The exporter and importer of non-medical masks must make a joint declaration confirming that (1) the masks meet Chinese or foreign standards, (2) the importer accepts the standards, and (3) the masks won’t be used for medical purposes.