Ecuador Medical Device Traceability: UMDNS and GMDN Coding and Article 68 Identification Cards

1. Key takeaways

Ecuadorian traceability rests on two rules. General provision four (CUARTA) requires manufacturers to use an internationally recognised common name or international nomenclature as the basis for coding the device, namely UMDNS, developed by ECRI, and GMDN. Article 68 requires the holder of an implantable device to enclose at least three identification cards in the packaging for traceability purposes, addressed respectively to the patient, the medical record, and the distributor or holder.

The exception in general provision four matters as much as the rule: where neither UMDNS nor GMDN covers a specific code for a device, the manufacturer may exceptionally use an alternative nomenclature published by a high health surveillance authority or referenced by the WHO. The exception is available, but it has to be reasoned rather than assumed.

The identification card under Article 68 carries four minimum data items: (a) the name of the device; (b) the batch or serial number; (c) the name of the manufacturer or primary manufacturer; (d) fields to be completed by the physician, covering patient information and the medical record.

2. Legal basis

Substance of general provision four: for device traceability purposes, manufacturers must adopt a common name or international nomenclature from an internationally recognised system as the coding basis, namely UMDNS as developed by ECRI and the GMDN nomenclature; where neither system covers a specific code for a device, the manufacturer may exceptionally use an alternative nomenclature published by a high health surveillance authority or referenced by the WHO.

3. Expert insights

Insight one: the traceability code is a nomenclature, not a barcode. What general provision four regulates is the common name or international nomenclature (denominación común o nomenclatura internacional), specifically UMDNS and GMDN. That is a different layer from the barcode used in distribution, such as GS1: the nomenclature identifies what the product is, while the barcode identifies the logistics unit. The two have to be planned separately, because satisfying one says nothing about the other.

Insight two: UMDNS and GMDN sit side by side, and an exception channel is open. The text names UMDNS as developed by ECRI and the GMDN nomenclature, and either may be used. Where neither offers a matching code, an alternative nomenclature published by a high health surveillance authority or referenced by the WHO is available exceptionally, and the use of that channel needs a documented justification in the file.

Insight three: Article 68 puts traceability into three cards rather than into a database. An implantable device must carry at least three identification cards: one for the patient, one for the medical record, and one for the distributor or holder. This is distributed record-keeping. The three copies back each other up, and any one of them can lead back to the product.

Insight four: the card and the batch code close the loop. The card must state the batch or serial number; Article 24, item 1.1 requires an explanation of what the batch code means; and Article 49, item (k) requires the batch number on the label. Read together, the three provisions let an implant be traced from a named patient back to a specific production batch.

Insight five: the duty bearer is the holder, but the card is usually made by the manufacturer. Article 68 places the obligation on the holder of the registration certificate for the implantable device, while the design and printing of the cards will normally be done at the manufacturing site. The division of labour has to be written into the holder agreement, including who pays for reprints after a packaging revision.

4. Practical recommendations

1. Assign a UMDNS or GMDN code to every model, and prepare justification material for the exceptional nomenclature where no code exists.
2. Design the three-card layout for implantable products so that all four Article 68 data items are present, including the physician fields.
3. Schedule card printing into the packaging revision plan in advance, in step with label finalisation rather than after it.
4. State in the agreement which party supplies the cards and which bears the cost, reflecting the split between holder obligation and manufacturer execution.
5. Align the batch numbering rule, the label batch number and the card batch number so that a single data source exists.

5. Verification checklist

• □ A UMDNS or GMDN code has been assigned to every model
• □ Justification for exceptional nomenclature has been prepared where no code exists
• □ Three identification cards have been designed for implantable products (patient, medical record, distributor)
• □ The cards contain the four minimum data items (name, batch number, manufacturer, physician fields)
• □ Card printing has been scheduled in the packaging revision plan
• □ The batch numbering rule is consistent across label, card and technical file

Regulatory information verified as of October 29, 2026

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