李国杰（经理）：18202125732 直线：021-61062636
产品国外准入要求
生产企业需确保出口的防疫物资质量符合进口国（地区）的要求及认证。
以下列出主要国外防疫物资技术要求供出口企业参考，具体内容及相关变化情况以相关管理部门、国外***机构***新公布为准。
近期欧美等***地区陆续发布防疫物资监管的临时或紧急措施，放宽部分防疫物资准入要求，如欧盟***会3月13日发布《关于COVID-19疫情期间的合格评定和市场监督程序的（EU）2020/403号建议》，提出正在进行认证程序的产品，只要达到欧盟技术***要求，可在一定期限内在欧盟市场上销售，但要确保认证工作会继续完成。欧盟成员国***或***机构可以采购没有CE标志的防护产品供医护人员使用，但不能进入常规销售渠道并提供给其他使用者。美国疾控中心（CDC）3月17日发布《优化N95口罩供应策略：危机/替代策略》，指出新冠***疫情期间，当N95口罩供给不足时，七个***和地区标准生产的口罩可作为替代品，其中包括按中国GB 2626-2006执行标准生产的四个口罩型号。但3月28日美国FDA又推出新的EUA，紧急批准了五个***和欧盟认证的非N95口罩，其中不包括中国生产的KN95口罩。（注;4月2日，美食药监负责***和科学事务的副专员阿南德·沙阿（Anand Shah）表示，该机构不再禁止从中国进口KN95口罩。目前，进口中国KN95口罩的合法性仍然不明确。）
Requirements for foreign access of products
The manufacturer shall ensure that the quality of the exported epidemic prevention materials meets the requirements and certification of the importing country (region).
The following is a list of the main technical requirements for foreign epidemic prevention materials for the reference of export enterprises. The specific contents and relevant changes shall be subject to the latest announcement of relevant management departments and foreign official agencies.
In recent years, European and American countries and regi*** h***e successively issued temporary or emergency measures for the supervision of epidemic prevention materials, and relaxed the access requirements for some epidemic prevention materials. For example, the European Commission issued the proposal (EU) No. 2020 / 403 on the conformity asses***ent and market supervision procedures during the covid-19 epidemic on March 13, proposing that products under the certification process can meet the requirements of EU technical regulati*** within a certain period of time Sell in EU market within the term, but make sure the certification work will continue to be completed. The official or authorized instituti*** of EU member states can purchase the protective products without CE mark for medical personnel, but they cannot enter the regular sales channels and provide them to other users. China's novel coron***irus pneumonia strategy was released in March 17th by the CDC. It pointed out that when the N95 mask was supplied with insufficient supply of new N95, the standard respirators produced in seven countries and regi*** could be used as substitutes, including four mask models according to the implementation of China GB 2626-2006 standard. However, on March 28, the US FDA launched a new EUA, which approved non-n95 masks certified by five countries and the EU, excluding kn95 masks made in China. (Note: on April 2, Anand Shah, Deputy Commissioner for medical and scientific affairs of CFDA, said the agency would no longer ban the import of kn95 masks from China. At present, the legitimacy of kn95 masks imported from China is still unclear.)
李国杰（经理）：18202125732 直线：021-61062636
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