GTIN Management for Medical Devices
Who Assigns the GTIN?
Who is responsible for assigning and managing GTIN’s on medical devices? Typically, the brand owner is responsible for every aspect of GTIN management. Where the medical device manufacturer is also the brand owner, they assign GTINs to all the products they market. Who assigns the GTIN when the medical device manufacturer is also the contract manufacturer? The same product sold under a different brand requires a different GTIN, which the private label company assigns. This is because they must be able to distinguish and track that product through a potentially different supply chain, monitor inventory depletion and replenishment, and implement an efficient recall if necessary.
Is a Changed Product a New Product?
New products always require a new GTIN. What is a new product? The simple answer is a product that is new to the market. A new product is one that did not previously exist in the brand owner’s offerings, or was not marketed by that brand owner. If the brand is introducing an altogether new product to the market, or a product to compete with a similar product already on the market, a new GTIN is required.
If a product changes, is it necessary to assign a new GTIN? Yes and no. The short answer is, any change to the product that the brand owner will want or need to track requires a new GTIN assignment to the changed product. Such changes could include sourcing an ingredient from a different supplier, adding or removing an ingredient from the existing product, or changing the formulation in any other way. This might include adding or changing a flavor, a coating, or some other “innocuous” modification.
Changes to the packaging of an otherwise unchanged product can also require a new GTN assignment. Changing the size or weight of the package can require a new GTIN. Changing the color scheme or adding a certification logo can also require a new GTIN assignment.
What About Updated Packaging?
Introducing the identical product a package with a different language necessitates a new GTIN, but adding a second language to the original packaging does not require a new GTIN. In addition, minor design changes or package sizing does not require a new GTIN.
Any change to a product that changes the regulatory or compliance statement, or which effects the way the product is shipped, stored or received requires a new GTIN assignment. There are some exceptions. Contact us for advice.
Corporate mergers and acquisitions present a unique challenge to GTIN managers. How do you handle the GTINs owned by the acquired company? The correct answer may require some research. Although the GTINs of the acquired company are an asset, you must be clear that they are an asset that conveyed to the acquirer, along with the other assets that came with the transaction. Legal advice recommended.
What About GTINs Acquired from a Merger?
If the GTINs do convey to the successor entity, check with GS1 to determine the statue of their licenses. Also, be aware that the license covers only the GS1 Company prefix portion of the GTIN. The product GTIN assignments can remain as long as none of the aforementioned changes are made. Otherwise, new GTIN’s are required.
These are the high points. There are myriad details that we have not covered. Questions? Contact us here.
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