醫療物資的FDA證書是哪個機構發放的？

Which organization issued the FDA certificate of medical materials?

答：美國FDA注冊是沒有證書的，產品通過在FDA進行注冊，將取得注冊號碼，FDA會給申請人一份回函(有FDA行政長官的簽字)，但不存在FDA證書一說。我們通常看到的這個證書是中介代理機構（注冊代理）簽發給廠家，以證明其幫助該廠家完成了美國FDA要求的“生產設施注冊和產品類型注冊”（Establishment Registration and Device Listing)，完成的標志是幫助廠家取得了FDA的注冊登記號。

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.

歐盟對口罩的準入要求有哪些？

What are the EU's access requirements for masks?

答：歐盟根據用途將口罩分為兩類：醫用口罩和個人防護口罩。醫用口罩需按照歐盟醫療器械指令93/42/EEC（MDD）或歐盟醫療器械條例EU2017/745（MDR）加貼CE標志，對應的標準是EN14683。根據口罩產品無菌或非無菌狀態，采取的合格評定模式也不同。無菌醫用口罩：必須由授權公告機構進行CE認證。非無菌醫用口罩：企業只需進行CE自我符合性聲明，不需要通過公告機構認證。在準備好相應文件及測試報告等資料后，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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