Hi,
When do we use the sentence, "Made in [Country of Origin/OEM Supplier]" on the medical device labels?
Excerpt from ASEAN Medical Device Directive draft is as follows:
Please note that "manufactured/made in Country X" or other similar wording
can only be printed on the labels if there is significant processing of the products in Country X.
The following are excluded: simple operations consisting of removal of dust, sifting or screening, sorting, classifying, matching (including the making up of sets of articles), washing, painting, cutting up; changes of packing and breaking up and assembly of consignments; simple placing in bottles, flasks, bags, cases, boxes, fixing on cards or boards, and all other simple packing operations; the affixing of marks, labels or other like distinguishing signs on products or their packaging; etc.
Any thoughts, whether it is a legal or trade compliance or customer requirement to have this statement on the label?
Thanks,
Sreenu
When do we use the sentence, "Made in [Country of Origin/OEM Supplier]" on the medical device labels?
Excerpt from ASEAN Medical Device Directive draft is as follows:
Please note that "manufactured/made in Country X" or other similar wording
can only be printed on the labels if there is significant processing of the products in Country X.
The following are excluded: simple operations consisting of removal of dust, sifting or screening, sorting, classifying, matching (including the making up of sets of articles), washing, painting, cutting up; changes of packing and breaking up and assembly of consignments; simple placing in bottles, flasks, bags, cases, boxes, fixing on cards or boards, and all other simple packing operations; the affixing of marks, labels or other like distinguishing signs on products or their packaging; etc.
Any thoughts, whether it is a legal or trade compliance or customer requirement to have this statement on the label?
Thanks,
Sreenu