醫(yī)療物資的FDA證書是哪個(gè)機(jī)構(gòu)發(fā)放的？

Which organization issued the FDA certificate of medical materials?

答：美國FDA注冊(cè)是沒有證書的，產(chǎn)品通過在FDA進(jìn)行注冊(cè)，將取得注冊(cè)號(hào)碼，F(xiàn)DA會(huì)給申請(qǐng)人一份回函(有FDA行政長(zhǎng)官的簽字)，但不存在FDA證書一說。我們通常看到的這個(gè)證書是中介代理機(jī)構(gòu)（注冊(cè)代理）簽發(fā)給廠家，以證明其幫助該廠家完成了美國FDA要求的“生產(chǎn)設(shè)施注冊(cè)和產(chǎn)品類型注冊(cè)”（Establishment Registration and Device Listing)，完成的標(biāo)志是幫助廠家取得了FDA的注冊(cè)登記號(hào)。

A: there is no certificate for FDA registration in the United States. If the product is registered in FDA, it will get the registration number. FDA will give the applicant a reply (signed by FDA Chief Executive), but there is no FDA certificate. The certificate we usually see is issued by the intermediary agency (registration agent) to the manufacturer to prove that it helps the manufacturer to complete the "establishment registration and device listing" required by the US FDA, and the completed mark is to help the manufacturer to obtain the FDA registration number.

歐盟對(duì)口罩的準(zhǔn)入要求有哪些？

What are the EU's access requirements for masks?

答：歐盟根據(jù)用途將口罩分為兩類：醫(yī)用口罩和個(gè)人防護(hù)口罩。醫(yī)用口罩需按照歐盟醫(yī)療器械指令93/42/EEC（MDD）或歐盟醫(yī)療器械條例EU2017/745（MDR）加貼CE標(biāo)志，對(duì)應(yīng)的標(biāo)準(zhǔn)是EN14683。根據(jù)口罩產(chǎn)品無菌或非無菌狀態(tài)，采取的合格評(píng)定模式也不同。無菌醫(yī)用口罩：必須由授權(quán)公告機(jī)構(gòu)進(jìn)行CE認(rèn)證。非無菌醫(yī)用口罩：企業(yè)只需進(jìn)行CE自我符合性聲明，不需要通過公告機(jī)構(gòu)認(rèn)證。在準(zhǔn)備好相應(yīng)文件及測(cè)試報(bào)告等資料后，即可自行完成符合性聲明。

A: the European Union divides masks into two categories according to their use: medical masks and personal protective masks. The medical mask shall be affixed with CE mark in accordance with EU medical device directive 93 / 42 / EEC (MDD) or EU medical device regulation eu2017 / 745 (MDR), and the corresponding standard is en14683. According to the aseptic or non aseptic state of the mask products, the conbity assessment mode adopted is also different. Sterile medical mask: it must be CE certified by an authorized notified body. Non sterile medical mask: enterprises only need to make CE self-compliance declaration, and do not need to pass the certification of the notified body. After preparing the corresponding documents, test reports and other data, the declaration of conbity can be completed by yourself.

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