產(chǎn)品國外準(zhǔn)入要求

生產(chǎn)企業(yè)需確保出口的防疫物資質(zhì)量符合進(jìn)口國（地區(qū)）的要求及認(rèn)證。

以下列出主要國外防疫物資技術(shù)要求供出口企業(yè)參考，具體內(nèi)容及相關(guān)變化情況以相關(guān)管理部門、國外官方機(jī)構(gòu)最新公布為準(zhǔn)。

近期歐美等國家地區(qū)陸續(xù)發(fā)布防疫物資監(jiān)管的臨時或緊急措施，放寬部分防疫物資準(zhǔn)入要求，如歐盟委員會3月13日發(fā)布《關(guān)于COVID-19疫情期間的合格評定和市場監(jiān)督程序的（EU）2020/403號建議》，提出正在進(jìn)行認(rèn)證程序的產(chǎn)品，只要達(dá)到歐盟技術(shù)法規(guī)要求，可在一定期限內(nèi)在歐盟市場上銷售，但要確保認(rèn)證工作會繼續(xù)完成。歐盟成員國官方或授權(quán)機(jī)構(gòu)可以采購沒有CE標(biāo)志的防護(hù)產(chǎn)品供醫(yī)護(hù)人員使用，但不能進(jìn)入常規(guī)銷售渠道并提供給其他使用者。美國疾控中心（CDC）3月17日發(fā)布《優(yōu)化N95口罩供應(yīng)策略：危機(jī)/替代策略》，指出新冠肺炎疫情期間，當(dāng)N95口罩供給不足時，七個國家和地區(qū)標(biāo)準(zhǔn)生產(chǎn)的口罩可作為替代品，其中包括按中國GB 2626-2006執(zhí)行標(biāo)準(zhǔn)生產(chǎn)的四個口罩型號。但3月28日美國FDA又推出新的EUA，緊急批準(zhǔn)了五個國家和歐盟認(rèn)證的非N95口罩，其中不包括中國生產(chǎn)的KN95口罩。（注;4月2日，美食藥監(jiān)負(fù)責(zé)醫(yī)療和科學(xué)事務(wù)的副專員阿南德·沙阿（Anand Shah）表示，該機(jī)構(gòu)不再禁止從中國進(jìn)口KN95口罩。目前，進(jìn)口中國KN95口罩的合法性仍然不明確。）

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 regions have 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 conbity assessment 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 regulations 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 institutions 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 coronavirus 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 regions 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 unb.)

李國杰（經(jīng)理）：18202125732 

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