INVIMA 2026 Fee Schedule for Medical Devices in Colombia

1. Key takeaways

The official fees for medical devices in Colombia for 2026 are set by Resolución 2025067543 (published December 22, 2025) and partially amended by Resolución 2026033499 (June 30, 2026). On the device side, fees are priced in UVB: registration and automatic renewal for class I/IIa at 321.91 UVB ≈ COP 3,898,330; registration and renewal for class IIb/III at 364.36 UVB ≈ COP 4,413,000; commercialization permit for controlled-technology equipment at 367.92 UVB ≈ COP 4,455,511. On the IVD side, fees are set directly in pesos: class I/II at COP 2,570,590 and class III at COP 3,427,327. Change fees are COP 826,546 for a change of legal nature and COP 1,060,243 for a change of technical nature.

GRZAN’s assessment is that official fees are only the first layer of cash outlay. The real cash cost also includes banking and payment costs at the payment step, document translation and authentication, local representative services, CCAA maintenance and testing fees. Converted at the current exchange rate, the official fees above fall roughly in the range of several hundred to just over one thousand US dollars (practical estimate, converted at the current exchange rate, for reference only). The verification entry point is the INVIMA website at https://www.invima.gov.co/tramites-y-servicios/tarifas.

2. Legal basis

3. Expert insights

#### UVB pricing means official fees rise each year with the unit value

The UVB (Unidad de Valor Básico) is a unit value adjusted with the price index, not a fixed peso amount. The figures 321.91 UVB and 364.36 UVB therefore remain stable within 2026, while the converted amounts COP 3,898,330 and COP 4,413,000 are the current-year values; when the UVB rises next year, the same UVB figures will map to higher peso amounts. GRZAN advises clients not to hard-code peso numbers in the budget: record the UVB figures plus a note converting at the UVB value of the applicable year.

#### The device and IVD pricing schemes cannot be interchanged

Devices are priced in UVB while IVDs are listed directly in pesos (COP 2,570,590 and COP 3,427,327). This reflects two independent classification systems: devices use the four classes I/IIa/IIb/III, while IVDs use the three Categorías I/II/III, and the two cannot be mapped onto each other. Budgeting IVD costs from the device UVB unit price will produce wrong conclusions.

#### Change fees regularly exceed clients’ expectations

At first registration, clients watch the registration fee, but what actually recurs is the change. A change of technical nature at COP 1,060,243 costs more than a change of legal nature at COP 826,546, reflecting the heavier review investment that technical modifications require. Over one product lifecycle, two or three technical changes can accumulate to a sum close to or even above the first registration fee (COP 3,898,330 or COP 4,413,000).

#### Real cash cost equals official fees plus payment friction plus third-party costs

Everything beyond the official fee belongs to the practical estimate: bank or payment-channel costs at the payment step, official Spanish translation, notarization and authentication of documents, local representative service fees, obtaining and maintaining the CCAA, and necessary testing and clinical documentation. At the market level, the fully bundled registration cost is about USD 2,000–3,000 per product (market quotation range, including official fees and service fees, converted at the current exchange rate, for reference only).

4. Practical recommendations

1. Finance: present device official fees in the budget as UVB figures, noting conversion to pesos at the UVB value of the applicable year.
2. GRZAN regulatory team: list official fees and service fees separately in quotations, citing Resolución 2025067543 as the source of the official fees.
3. Registration specialist: re-check current amounts at https://www.invima.gov.co/tramites-y-servicios/tarifas before submission and confirm whether the Resolución 2026033499 amendment affects them.
4. Project manager: reserve a budget for at least one change of technical nature per product at COP 1,060,243.
5. Commercial: when quoting to channel partners, include an exchange-rate linkage clause – peso official fees are converted at the current exchange rate, for reference only.
6. Finance: confirm with the bank the cross-border payment fees and confirmation lead time (practical estimate) and reserve a time buffer.

5. Verification checklist

• □ The product’s channel is confirmed: device Art. 16/17 or IVD Decreto 3770
• □ Device official fees recorded as UVB figures: class I/IIa 321.91 UVB, class IIb/III 364.36 UVB
• □ The controlled-technology permit is included at 367.92 UVB (≈ COP 4,455,511)
• □ IVD official fees included at COP 2,570,590 (I/II) or COP 3,427,327 (III)
• □ The change budget includes COP 826,546 for change of legal nature and COP 1,060,243 for change of technical nature
• □ Current amounts have been re-checked on the INVIMA fee page
• □ An exchange-rate linkage clause is included in external quotations (converted at the current exchange rate, for reference only)
• □ Bank fees and confirmation lead time for the payment step are confirmed (practical estimate)

• GRZAN regulatory team

Regulatory information verified as of October 29, 2026

All conclusions published here are based on the current regulatory texts issued by the competent authority and are verified item by item before delivery.

GRZAN provides manufacturers entering the Colombian market with complete fee budgeting under the 2026 Manual Tarifario, UVB-based cost modeling, and local licensed-entity and importer support, so the true cash cost of registration is known before you commit. For a costed registration plan, contact us at info@grzanglobal.com.