1. As you said, the process here in Mexico with the FSC, is as follow: you receive the FSC apostilled or legalized Original and make a certified copy of it. (Because you never give to Cofepris an original or the document that you receive. This is because Cofepris sometime can lose the submission, and in that case, you have the original and can do another certified copy.) I think If you can make a certified copy, we ship you two or three scanned copies of FSC then you certify them. Is it acceptable for you? 2. The FSC from EU representative The documents to be apostilled must be original, with the signature of the competent authority previously registered in the Ministry of Foreign Affairs. The scanned copy can’t be apostilled in Germany. 3. The normal rule is to the apostille in the Country where the document was done. The ISO 13485 was issued by the Chinese branch of TÜV SÜD in China. And GMP was issued in Brazil. The scanned copies of them cannot be apostilled in Germany either. 4. The original ISO and GMP for Alltest is not apostilled. I am confused about why EC certificate for swab Jiangsu Changfen Medical Industry Co., Ltd. need to be apostilled where it was issued. 5.What else documents in the checklist need to be apostilled or legalized? Could you please give me a list of them? Legalized Original Chinese FSC The three PoAs (the representative, distributor, the letter for FSC) Apostilled EC certificate for swab Jiangsu Changfen Medical Industry Co., Ltd The scanned copies (FSC from EU representative, ISO, GMP) 6.You said you need analytical certificates for PP and PU. We have provided the Safety Data Sheet to show the material. We also provided biocompatibility test to show the material is no harm for human. Are the certificates necessary for the product material? Can we register without the certificates? 7.As you said in the mail, the document “3.3 Specification information of Swab” is fine but the authority likes to see a document with the title “Analytical certificate” like the one you attach. I saw the Certificate of Analysis swab draft but I send you the COA of product. If it is not necessary for us to provide the Certificate of Analysis of swab, then the Specification information of Swab is ok with the registration. 8. Can we register more than one distributor within the first submission? For example, if we register two or three distributors, will it cost additional fee?
