Labeling and Instructions for Use Under Resolución 1405 de 2022

1. Key takeaways

Labeling (rotulado) and the instructions for use (instructivo) in Colombia are not auxiliary pages of the technical documentation; they are a direct extension of the registration certificate. All submission documents must be in Spanish, with technical or scientific information permitted to carry an official Spanish translation, and this language rule leaves no exception at the labeling stage, because the users of the label are end-user healthcare institutions and patients.

What truly doubles the labeling workload is the semantic standard established by Resolución 1405 de 2022 (published August 8, 2022): it brings the UDI-DI, the GMDN code and terminology, the registration number, manufacturer information, risk classification, storage and packaging conditions, and the commercial package unit and minimum use unit all into structured attributes. The transition period ended on February 8, 2026 with the expiry of the 24-month window for Class IIa and Class I devices, and INVIMA officially confirmed on March 12, 2026 that semantic reporting is now fully mandatory.

2. Legal basis

3. Expert insights

#### 1. The semantic standard turns labeling from a layout problem into a data problem

Resolución 1405 de 2022 splits label content into three classes of attributes: basic, regulatory and commercial. Basic attributes include the UDI-DI, the GMDN code and terminology, the registration number and the issuing agency; regulatory attributes include manufacturer information, risk classification and special storage and packaging conditions; commercial attributes include the commercial description, the commercial package unit and the minimum use unit. GRZAN’s judgment is that this structure means every field on the label must share a single source with the application data. Manual layout and field-by-field transcription inevitably produce inconsistencies after any data change, and those inconsistencies surface as deficiencies or, worse, as findings in post-grant control.

#### 2. The transition period has fully expired, and the issuing agency can only be chosen from the designated range

The transition was tiered by risk class: registrations obtained from February 8, 2024 onward had to comply before commercialization; Class III devices and IVD Class III had 12 months, until February 8, 2025; Class IIb devices and IVD Class II had 18 months, until August 8, 2025; and Class IIa devices, Class I devices and IVD Class I had 24 months, until February 8, 2026. The issuing agency is limited to GS1, HIBCC, ICCBBA, IFA, Ali Health and ZIIOT. GRZAN warns that choosing the wrong issuing agency means the UDI-DI cannot enter the INVIMA system, and no matter how well the label is designed, the semantic report can never be completed.

#### 3. Three content red lines

The first is the language red line: labels and instructions for use facing users and patients must be in Spanish, and an English original cannot stand alone as the deliverable. The second is the entity red line: the name and address of the titular on the label must match the certificate items stated under Art. 20, and a corporate name change not synchronized onto the label is a problem that post-grant control hits directly. The third is the claims red line: indications and performance claims must not exceed the evidence supported by the technical documentation, and any therapeutic statement unsupported by clinical or performance data escalates a labeling issue into a product compliance issue. All three lines are cheap to respect at design time and expensive to cross after printing.

#### 4. The registration number format is a hard field on the label

The registration number follows the example format INVIMA 2025DM-0002510-R2, where the R suffix indicates the renewal count. This field cannot be omitted or abbreviated on the label. GRZAN recommends reserving layout margin for the registration number position at the label design stage, so that a change in the number of digits after a renewal does not force the entire printing plate to be remade. The cost of this margin is trivial at design time and significant once artwork has already been finalized and plates cut for production.

4. Practical recommendations

1. Have GRZAN issue the field list before label design, mapping each field item by item to the basic, regulatory and commercial attribute classes of Resolución 1405 de 2022.
2. Have the foreign manufacturer select the issuing agency from GS1, HIBCC, ICCBBA, IFA, Ali Health and ZIIOT and complete UDI-DI assignment.
3. Have native Spanish reviewers finalize the label and instructions for use renderings, keeping medical terminology consistent with GMDN terminology.
4. Have the registration specialist verify that the titular name, address and registration number on the label match the items required under Art. 20 word for word.
5. Have marketing and regulatory sign off jointly on indications and performance claims, ensuring every claim traces back to an evidence entry in the technical documentation.
6. Have GRZAN re-verify the label layout after every renewal or change, preventing rework caused by a change in the digit count of the registration number.

5. Verification checklist

• □ Labels and instructions for use are in Spanish, with no untranslated English deliverables
• □ UDI-DI assignment is complete, with the issuing agency among GS1, HIBCC, ICCBBA, IFA, Ali Health and ZIIOT
• □ Basic attributes are complete: UDI-DI, GMDN code and terminology, registration number, issuing agency
• □ Regulatory attributes are complete: manufacturer information, risk classification, special storage and packaging conditions
• □ Commercial attributes are complete: commercial description, commercial package unit, minimum use unit
• □ The name and address of the titular match the items required under Art. 20 word for word
• □ Every indication and performance claim traces back to an evidence entry in the technical documentation

Regulatory information verified as of October 29, 2026

All conclusions for external use are based on the current regulatory texts published by the competent authorities and are verified item by item before delivery.

GRZAN supports manufacturers entering the Colombian market with registration dossiers and conformity documentation, including label field mapping under Resolución 1405 de 2022, UDI-DI implementation, Spanish label and instructions for use preparation and claims review for INVIMA submissions. For inquiries, contact info@grzanglobal.com.