Medical devices must pass through two systems at the same time: the regulatory-side UDI (Unique Device Identification) and the circulation-side trade item barcode. The two identification systems have different roles and can coexist; the key is not to let one replace the other.
The example is a trade item unit GTIN-13 (including the mod10 check digit). UDI is carried separately as required by regulation.
UDI Compliance Identification — first identify your situation, then look at the solution.
Treating UDI and product barcodes as the same thing, so neither is done correctly.
Regulatory identifiers and product identifiers have different requirements for carrier, location, and content.
Regulatory requirements are met, but the GTIN for the supermarket / e-commerce distribution side has not been obtained.
In the device scenario, barcodes serve as a "dual-track identification": UDI is for regulatory traceability (carried via GS1 DataMatrix and other carriers as required by regulation), while GTIN-13 is for retail and distribution settlement. The two run in parallel without conflict.
Carry the unique device identifier using GS1 standards as required by regulation.
Settlement and record creation for retail distribution units such as supermarkets / e-commerce.
The two sets of identifiers are placed on the label according to their respective specifications.
Choose barcode types by scenario, and don't pay for capabilities you won't use.
| Barcode symbology | Form | Purpose in this scenario |
|---|---|---|
| GTIN-13 | Trade item unit | Settlement and record creation for retail and e-commerce channels. |
| UDI carrier | GS1 DataMatrix | Carries the unique device identifier according to current regulatory requirements. |
| ITF-14 | Outer carton | Full-carton logistics identifier. |
All barcode types can be found inBarcode Tool CenterTruly generated and verified before printing.
Directional comparison; specific current rules shall prevail.
| Identification | For | Notes |
|---|---|---|
| UDI | Regulatory Traceability | Implemented in accordance with the current requirements for medical device regulation; carriers and content are subject to official rules |
| GTIN-13 | Product Circulation | Retail / e-commerce channel filing and settlement |
| Label Layout | Two sets coexist | Each is printed in its specified position according to the specifications, without obscuring the other |
| Outer carton | ITF-14 | Carton Logistics Identification |
The implementation scope, carriers, and timetable of UDI are subject to the current announcements of the regulatory authority; this solution assists with coding and overall label planning on the product circulation side.
List the devices requiring UDI and the circulation units requiring product codes by product line.
GTIN-13 covers circulation units, and outer cartons are assigned ITF-14.
UDI carriers and product barcodes are laid out in separate zones on the label without interfering with each other.
The regulatory side verifies according to official requirements, and the circulation side conducts sample printing and scanning verification.
GTIN-13 + ITF-14 level pairing: product codes correspond to outer carton codes, making the distribution hierarchy clear.
Manufacturing enterprises such as Skyworth.
The medical device category usually also requires product registration / filing information (subject to the current requirements of regulators and platforms).
The total fee usually includes: the coding service fee charged by the member organization (based on tier and number of years) + agency service fee. Factors affecting the fee: SKU scale, number of number segments required, and whether additional matters such as changes / transfers are included.
Once the materials are complete, the review and allocation process begins. Timelines vary by member organization.
No new code allocation is involved, so the process is relatively simple
Unified ledger management, with each milestone synchronized item by item
The above is a description of the process sequence and does not fabricate specific numbers of days; the actual timeline is subject to the current public notices of the accepting institution, and each milestone will be synchronized during processing.
Describe the product category and sales channel, and the coding consultant will provide the corresponding solution for this scenario.
