Dear Sir's,
We manufacture a single use ophthalmic medical devices and are packed in primary pack of Tyvek pouch & bulk packing in a carton boxes, sterilized by Ethylene Oxide from us (manufacturer) and labelled as a 'do not resterilize' (Single use). now one of my customer wants to purchase a sterile pack and he wants to put it in to custom kit pack and do the reserialization by ETO for my medical device.
My question is that, the distributor/ customer can do the Re-sterilization of my medical device product again and do the marketing.
Please advise:
Thanks in advance
We manufacture a single use ophthalmic medical devices and are packed in primary pack of Tyvek pouch & bulk packing in a carton boxes, sterilized by Ethylene Oxide from us (manufacturer) and labelled as a 'do not resterilize' (Single use). now one of my customer wants to purchase a sterile pack and he wants to put it in to custom kit pack and do the reserialization by ETO for my medical device.
My question is that, the distributor/ customer can do the Re-sterilization of my medical device product again and do the marketing.
Please advise:
Thanks in advance