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  • 1.  Confirmation Letter for Disposable products- Vietnam

    This message was posted by a user wishing to remain anonymous
    Posted 05-May-2022 10:04
    This message was posted by a user wishing to remain anonymous

    Hello All-
    I was curious if anyone else has come across the request from MOH to provide a letter confirming a medical device is disposable, even though the single- use symbol, and clear statement of the single- use nature of the device is provided on the product label and in the IFU. Are they looking for more explanation regarding HOW to dispose of the device? I'm just curious what the letter would say that isn't already provided with the product. 

    Thanks!


  • 2.  RE: Confirmation Letter for Disposable products- Vietnam

    This message was posted by a user wishing to remain anonymous
    Posted 23-May-2022 09:07
    This message was posted by a user wishing to remain anonymous

    No experience in Vietnam, but similar peculiarities from time to time in other countries...

    I've been asked for a letter confirming there is no expiration date on the label, which is another thing they could see by looking at the label. I'm guessing the letter might be to support a record that will be used at some point for comparison to the label to ensure it is as expected.

    I've also been asked for a letter confirming a product is FDA-listed, which seems even more odd, since you might think they could look at the FDA databases online with more confidence, or in the CFG.

    I just assume it's helping somebody's process somehow, and write a letter.