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Hello everybody, I am looking for any registration information or guideline of CE-marked IVDs in Tunisia. What do I ahave to do as Legal Manufacturer to sell my products to this country? Thanks a lot for any links. Best. ------------------------------ Melanie Martini Berlin Germany ...

Hello everybody, Another post about CFDA registration... Can anyone provide detailed information about the "green channel" registration process? I am looking for anything as - What are the specific requirements that allow to apply for this kind of approval - How do you get in contact with CFDA for ...

Hi Ginger, Thanks for the information. Do you have experience regarding Q-sub records? Do the records provide more information than the ones the meeting participants have on hand already? I am referring to e.g. internal FDA discussions about the meeting or FDA decision making after the meeting? ...

Hello, I attached two documents I found for MDs and IVDs. But only the IVD list is translated to English. Worked pretty well with Google translater. Hope, you find what you are looking for. Best. ------------------------------ Melanie Martini Berlin Germany ------------------------------

Hi all, I am not sure but I thought that I had read in some discussion that you can request the FDA meeting records of pre-sub meetings. Is that correct and if yes, how do I apply for these records? Thanks, Melanie ------------------------------ Melanie Martini Berlin Germany ---------- ...