Does Package Validation required for Service Parts Packaging Carton Box?

sreenu927

Quite Involved in Discussions
Hii..

Does package validation required for service spare parts and accessories packaging?
This accessories/service parts will be packed in a separate carton box.
This carton box will be sold as part of the medical device.

Thanks,
Sreenu
 
M

MIREGMGR

If it's a medical device and its safety or effectiveness could be affected by something that might occur between production and use, then yes, validated packaging performance is required. Whether the medical device is designated a "spare part" or "accessory" or whatever is irrelevant.
 
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