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Dear fellow colleagues in the medical device field,
We have a skin product ready and classification will be IIb.
At this moment we only have accelerated stability data, only performed on 1 batch, results are good.
Can we already commercialize the product and have it on the Market?
Can we claim a 2 or 3 year expiry date shelf life for the product and be on the Market with only results from the accelerated study.
We commit ourselves to start up stability according ICH, long-term, 3 batches, etc.
Are there any regulations pointing at this in de ISO13485 or other guidelines that tell what is necessary to be on the Market regarding shelf life/aging data?
Kind regards
We have a skin product ready and classification will be IIb.
At this moment we only have accelerated stability data, only performed on 1 batch, results are good.
Can we already commercialize the product and have it on the Market?
Can we claim a 2 or 3 year expiry date shelf life for the product and be on the Market with only results from the accelerated study.
We commit ourselves to start up stability according ICH, long-term, 3 batches, etc.
Are there any regulations pointing at this in de ISO13485 or other guidelines that tell what is necessary to be on the Market regarding shelf life/aging data?
Kind regards
