Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

For ISO 15223-1:2021 Symbol 5.1.11 (Country of Manufacture), is it appropriate to use this symbol (along with the 2-digit country code within) to represent your plant of manufacture? The symbol would be used with the name / address of the plant adjacent (similar to how the manufacturer 5.1.1 symbol is being used).

When reviewing the symbol definition and accompanying appendix entry in the ISO, it seems to imply that the symbol should only be used to represent a country of manufacture (perhaps with the granularity that the manufacturing plant is not in the same country as the legal manufacturer).

If that understanding is indeed accurate, is there a cleaner way to represent plant of manufacture on product labeling?

Thanks in advance for your input!

Dear Anon,

We have a similar situation in our company, specifically to cover a requirement for the registration in India. Honestly, I don't see an issue in using this symbol together with the manufacturing site's address adjacent to it. Just make sure that the date of manufacture is not added near it, especially if the dedicated symbol is already present on the label, as they are mutually exclusive.

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Monica Fabris
Anika Therapeutics, Inc. - ENTERPRISE
Bedford MA
United States
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Original Message:
Sent: 03-Jan-2024 13:57
From: Anonymous Member
Subject: Annotating Plant of Manufacture - Country of Symbol use?

This message was posted by a user wishing to remain anonymous

For ISO 15223-1:2021 Symbol 5.1.11 (Country of Manufacture), is it appropriate to use this symbol (along with the 2-digit country code within) to represent your plant of manufacture? The symbol would be used with the name / address of the plant adjacent (similar to how the manufacturer 5.1.1 symbol is being used).

When reviewing the symbol definition and accompanying appendix entry in the ISO, it seems to imply that the symbol should only be used to represent a country of manufacture (perhaps with the granularity that the manufacturing plant is not in the same country as the legal manufacturer).

If that understanding is indeed accurate, is there a cleaner way to represent plant of manufacture on product labeling?

Thanks in advance for your input!

Hello Anon,

Your assumption is correct because if you add address and contact information adjacent to this symbol, this could potentially be confused with the (legal) Manufacturer.  In the description from the standard, it states the date of manufacture could be placed adjacent to this symbol, but not the actual manufacturing site.  We have had this discussion before about clearly identifying the location of actual manufacturing and how this can be conveyed.  Typically this would be something in the Instructions for Use (IFU).  Placing this on the actual device label could be confusing again with the "factory symbol" indicating the entity who is the actual (legal) Manufacturer.  Unfortunately, there is not a symbol to indicate the actual manufacturing site, such as when the company is multi-national and large with multiple facilities, so this is usually indicated in the IFU.  Other companies use other indicators for the customers or internally to indicate the actual manufacturing site such as designators in the Product Identification, such as part number, or in the Product Traceability, such as the serial number or lot number.

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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
Oriel STAT A MATRIX - ENTERPRISE
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Original Message:
Sent: 03-Jan-2024 13:57
From: Anonymous Member
Subject: Annotating Plant of Manufacture - Country of Symbol use?

This message was posted by a user wishing to remain anonymous

For ISO 15223-1:2021 Symbol 5.1.11 (Country of Manufacture), is it appropriate to use this symbol (along with the 2-digit country code within) to represent your plant of manufacture? The symbol would be used with the name / address of the plant adjacent (similar to how the manufacturer 5.1.1 symbol is being used).

When reviewing the symbol definition and accompanying appendix entry in the ISO, it seems to imply that the symbol should only be used to represent a country of manufacture (perhaps with the granularity that the manufacturing plant is not in the same country as the legal manufacturer).

If that understanding is indeed accurate, is there a cleaner way to represent plant of manufacture on product labeling?

Thanks in advance for your input!