Export of medical supplies with European and American certifications and no Chinese certifications is prohibited since April 1
On March 31, the Ministry of Commerce, the General Administration of Customs and the State Drug Administration jointly issued the "Announcement on the Orderly Development of the Export of Medical Materials". Since April 1, export of new coronavirus detection reagents, medical masks, and medical protection When customs, ventilator, and infrared thermometers declare to the customs, they must provide a written or electronic declaration, promising that the export products have obtained China's medical device product registration certificate and meet 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. Relevant medical material export enterprises should ensure product quality and safety, meet relevant standards and requirements, and actively support the international community in fighting the epidemic.
"Our export license was canceled. Originally, exporting only required to obtain overseas sales qualifications. Now it is directly affected. We intend to appeal to the Ministry of Commerce and hope not to cut everything." On April 1, a diagnostic reagent company The person in charge disclosed exclusively to the 21st Century Business Herald reporter that at present many companies have been notified that their export licenses have been cancelled.
On the afternoon of March 31, the Drug Supervision Department of the State Food and Drug Administration held a video conference on the deployment of key tasks for drug supervision in 2020.
The meeting emphasized that drug regulatory departments at all levels must implement the decision-making and deployment of the Party Central Committee and the State Council, resolutely do a good job of drug quality supervision related to epidemic prevention and control, and require that the quality of export drugs be properly supervised, and the management of drug export certification be strictly regulated. Comply with the conditions and requirements for certificate issuance, fail to comply with China's pharmaceutical GMP, etc., and resolutely revoke its drug export certification according to law; continue to strengthen drug production supervision and effectively ensure that the quality of exported drugs meets requirements; strengthen coordination with market supervision, customs, public security and other departments , Severely crack down on violations of laws and regulations.
As of April 1, the State Food and Drug Administration has approved 23 new coronavirus detection reagents, including 15 nucleic acid detection reagents and 8 antibody detection reagents.
It is understood that many companies have obtained EU certification for sales, but have not obtained domestic registration certificates.
Breaking News From China Government: Export of medical supplies without chinese certification is prohibited since April 4 including those with European and American certifications
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