Good question. Do you mean approval documents? I had same question. With drugs there is process for making public documents that describe assessment of the drug that has been approved by regulator . EPAR in Europe is one example or AUSPAR in Australia. I’m uncertain if such similar document is ever made public by notified body for a medical device.
but there should be a mandatory package insert or product information document approved by BSI that the company should provide once product approved and ready to sell. As I mentioned in an earlier post I was surprised to find this absent on OSL website when I looked few days ago.
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oncosil medical ltd
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Good question. Do you mean approval documents? I had same...
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