NMPA general administration of Announcement No. 5,2020

Published in:2020-04-14

At present, the global epidemic is spreading rapidly.On the basis of good epidemic prevention and control, orderly export of medical materials is an important measure to deepen international cooperation on epidemic prevention and control and jointly tackle the global public health crisis.In epidemic prevention and control of special period, to effectively support the global fight against the disease, to ensure product quality and safety, standardize the order of export, since April 1, the export will be coronavirus detection reagent, surgical masks, medical protective clothing, breathing machine, infrared thermometer enterprise declare to the customs, shall provide a written or electronic statement (see appendix 1). Commitment to export products have made our country medical equipment product registration certificate (see attachment 2) relevant registration information, as to meet the requirements of the quality standards of importing countries (regions).The customs shall release the medical device product registration certificate approved by the pharmaceutical supervisory and administrative department.The above-mentioned quality control measures for the export of medical materials will be adjusted dynamically according to the development of the epidemic situation.
Relevant exporting enterprises of medical materials should ensure the quality and safety of their products, meet relevant standards and requirements, and actively support the international community in fighting against the epidemic.
 
 
Annex: 1. Template for declaration of export medical materials. Doc
             2. China's relevant medical device product registration information (dynamic update on sfda website www.nmpa.gov.cn). XLSX
 
                                                                                    National drug administration, general administration of customs, ministry of commerce
                                                                                                                                                                                                      March 31, 2020

出口医疗物资声明模板.doc

我国相关医疗器械产品注册信息(国家药监局网站www.nmpa.gov.cn动态更新).xlsx.xlsx