China Official Announcement of exporting reagents for detection of the novel coronavirus

In order to effectively support the global fight against the epidemic COVID-19, to ensure product quality and safety, and to standardize the sequence of exports during this special period of epidemic prevention and control, China Ministry of Commerce and China Customs released announcement on March 31, 2020, which the Chinese enterprises exporting reagents for detection of the novel coronavirus, medical masks, medical protective clothing, ventilators, and infrared thermometers must provide written or electronic declarations (see Attachment 1 for the template) promising that the exported products have obtained China’s medical device product registration certificates (see Attachment 2 for relevant registration information) and meet the quality standard requirements of importing countries (regions). Customs shall rely on medical device product registration certificates approved by the drug supervision and administration departments in processing. The aforementioned quality control measures for the export of medical materials will be dynamically adjusted in light of the developing epidemic situation.

Relevant enterprises exporting medical materials should ensure the quality and safety of their products and that they meet the requirements of relevant standards, to actively support the international community in fighting the epidemic together.

Attachments:

1. Template Declaration for Export of Medical Supplies.doc

2. China Relevant medical device product registration information.xlsx

 

 

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