Colombia medical device regulations

FM006v13 places brand addition/change/exclusion under legal4001-36, with revised labels and insert, trademark status and third-party use permission where relevant, and manufacturer authorization where the brand is not the manufacturer’s. The exclusion justification may be entered in observations as stated. Do not import the logo/barcode/color exemption from older FM006v12 into this current matrix.

The adopted2026 tariff lists automatic MD/IVD legal modification4001-36 at 71.55 UVB, technical4001-37 at 91.78 UVB, and combined legal/technical4001-38 at 103.99 UVB. The captured official workbook (historically acquired as V5) gives COP866,471;1,111,456;1,259,319 respectively at 2026 UVB12,110. Conditional microenterprise exemptions90116/17/18 depend on Law2069 Art. 2§2; they are not a universal zero fee.

Both current matrices identify legal-only4001-36, technical-only4001-37 and combined legal+technical4001-38. Select every actual requested item and provide each block’s evidence for the affected registration. This supports a combined application category, not unlimited grouping of unrelated registrations, holders or products. In the IVD form, adding information does not remove existing approved information: expressly request the intended removal/change as well.

The July 2026 UDI manual says the transition ended8February2026 and reporting is a premarket condition from 9February2026 for authorized MD/IVD being marketed. Report the exact brand, manufacturer, model/reference/presentation and associated UDI-DI consistently with the sanitary registration. Editing a brand in the reporting interface does not approve a registration modification. These sources do not require a new UDI-DI for every internal REF change; identify the issuer-assigned DI and actual device change.

The IVD automatic-modification term is two days following evaluation of the submitted documents, with subsequent review. Decree 581 Art. 6 separately gives30 working days to respond to post-review information requests and then provides suspension/cancellation conditions; neither that cure period nor the 90-working-day initial-registration period is a variation decision term.

The current modification matrix treats manufacturer corporate-name change as legal modification4001-36. For a foreign company, provide competent-origin-authority existence/name evidence, rather than a self-issued company document, or the accepted CFS showing the amended details with the required manufacturer declaration where stated. Submit labels reflecting the new manufacturer name and any applicable updated insert; do not introduce other unrequested label changes.

The adopted2026 tariff lists automatic MD/IVD legal modification4001-36 at 71.55 UVB, technical4001-37 at 91.78 UVB, and combined legal/technical4001-38 at 103.99 UVB. The captured official workbook (historically acquired as V5) gives COP866,471;1,111,456;1,259,319 respectively at 2026 UVB12,110. Conditional microenterprise exemptions90116/17/18 depend on Law2069 Art. 2§2; they are not a universal zero fee.

Both current matrices identify legal-only4001-36, technical-only4001-37 and combined legal+technical4001-38. Select every actual requested item and provide each block’s evidence for the affected registration. This supports a combined application category, not unlimited grouping of unrelated registrations, holders or products. In the IVD form, adding information does not remove existing approved information: expressly request the intended removal/change as well.

The July 2026 UDI manual says the transition ended8February2026 and reporting is a premarket condition from 9February2026 for authorized MD/IVD being marketed. Report the exact brand, manufacturer, model/reference/presentation and associated UDI-DI consistently with the sanitary registration. Editing a brand in the reporting interface does not approve a registration modification. These sources do not require a new UDI-DI for every internal REF change; identify the issuer-assigned DI and actual device change.

The IVD automatic-modification term is two days following evaluation of the submitted documents, with subsequent review. Decree 581 Art. 6 separately gives30 working days to respond to post-review information requests and then provides suspension/cancellation conditions; neither that cure period nor the 90-working-day initial-registration period is a variation decision term.

Manufacturer name/domicile blocks permit the stated competent-authority evidence or accepted CFS alternative showing the amended details. Actual manufacturer replacement/addition has distinct CFS requirements identifying manufacturer and product/references. Product-name changes have their own supporting CFS provision. Do not infer that every brand/artwork/internal-code change needs a new CFS, or that a holder assignment alone changes the foreign manufacturer.

The current manufacturer-domicile block is legal modification4001-36 and requires origin-authority/company evidence or an accepted CFS reflecting the changed address, plus labels and applicable inserts showing the new domicile. The IVD address block also lists quality/sanitary certificate evidence; retain that requirement for the actual manufacturer arrangement rather than assuming an office move is a plant relocation.

The adopted2026 tariff lists automatic MD/IVD legal modification4001-36 at 71.55 UVB, technical4001-37 at 91.78 UVB, and combined legal/technical4001-38 at 103.99 UVB. The captured official workbook (historically acquired as V5) gives COP866,471;1,111,456;1,259,319 respectively at 2026 UVB12,110. Conditional microenterprise exemptions90116/17/18 depend on Law2069 Art. 2§2; they are not a universal zero fee.

Both current matrices identify legal-only4001-36, technical-only4001-37 and combined legal+technical4001-38. Select every actual requested item and provide each block’s evidence for the affected registration. This supports a combined application category, not unlimited grouping of unrelated registrations, holders or products. In the IVD form, adding information does not remove existing approved information: expressly request the intended removal/change as well.

The July 2026 UDI manual says the transition ended8February2026 and reporting is a premarket condition from 9February2026 for authorized MD/IVD being marketed. Report the exact brand, manufacturer, model/reference/presentation and associated UDI-DI consistently with the sanitary registration. Editing a brand in the reporting interface does not approve a registration modification. These sources do not require a new UDI-DI for every internal REF change; identify the issuer-assigned DI and actual device change.

The IVD automatic-modification term is two days following evaluation of the submitted documents, with subsequent review. Decree 581 Art. 6 separately gives30 working days to respond to post-review information requests and then provides suspension/cancellation conditions; neither that cure period nor the 90-working-day initial-registration period is a variation decision term.

Manufacturer name/domicile blocks permit the stated competent-authority evidence or accepted CFS alternative showing the amended details. Actual manufacturer replacement/addition has distinct CFS requirements identifying manufacturer and product/references. Product-name changes have their own supporting CFS provision. Do not infer that every brand/artwork/internal-code change needs a new CFS, or that a holder assignment alone changes the foreign manufacturer.

FM006v13 expressly lists change, addition or exclusion of references in the technical4001-37 K/K1/K2 block. Supply the updated insert/labels and justification requested by that block, with exact old/new details. The supporting text itself repeats presentation wording; it must not be silently rewritten into a different legal test. An order code matters only when it maps to the authorized reference/presentation.

The adopted2026 tariff lists automatic MD/IVD legal modification4001-36 at 71.55 UVB, technical4001-37 at 91.78 UVB, and combined legal/technical4001-38 at 103.99 UVB. The captured official workbook (historically acquired as V5) gives COP866,471;1,111,456;1,259,319 respectively at 2026 UVB12,110. Conditional microenterprise exemptions90116/17/18 depend on Law2069 Art. 2§2; they are not a universal zero fee.

Both current matrices identify legal-only4001-36, technical-only4001-37 and combined legal+technical4001-38. Select every actual requested item and provide each block’s evidence for the affected registration. This supports a combined application category, not unlimited grouping of unrelated registrations, holders or products. In the IVD form, adding information does not remove existing approved information: expressly request the intended removal/change as well.

The July 2026 UDI manual says the transition ended8February2026 and reporting is a premarket condition from 9February2026 for authorized MD/IVD being marketed. Report the exact brand, manufacturer, model/reference/presentation and associated UDI-DI consistently with the sanitary registration. Editing a brand in the reporting interface does not approve a registration modification. These sources do not require a new UDI-DI for every internal REF change; identify the issuer-assigned DI and actual device change.

The IVD automatic-modification term is two days following evaluation of the submitted documents, with subsequent review. Decree 581 Art. 6 separately gives30 working days to respond to post-review information requests and then provides suspension/cancellation conditions; neither that cure period nor the 90-working-day initial-registration period is a variation decision term.

Manufacturer name/domicile blocks permit the stated competent-authority evidence or accepted CFS alternative showing the amended details. Actual manufacturer replacement/addition has distinct CFS requirements identifying manufacturer and product/references. Product-name changes have their own supporting CFS provision. Do not infer that every brand/artwork/internal-code change needs a new CFS, or that a holder assignment alone changes the foreign manufacturer.

The holder-change block is legal modification4001-36. The assignment/acceptance may be one jointly signed document or separate consent and acceptance documents, signed by the legal representatives of assignor and assignee. Identify registration, expediente, product and brand where relevant, and provide the manufacturer/authorized party’s document establishing its relationship with the assignee. A local holder assignment is distinct from replacing a foreign manufacturer.

The current manufacturer-change/addition block requires evidence that the authorized product characteristics remain unchanged, the new manufacturer’s competent-authority/QMS evidence, CFS identifying the manufacturer and product/references where applicable, updated labels/inserts, and a documented relationship between approved and new manufacturers, such as the specified manufacturing agreement, group-company proof or CFS naming the legal manufacturer and plant. It is not satisfied by a same-person name letter alone.

The adopted2026 tariff lists automatic MD/IVD legal modification4001-36 at 71.55 UVB, technical4001-37 at 91.78 UVB, and combined legal/technical4001-38 at 103.99 UVB. The captured official workbook (historically acquired as V5) gives COP866,471;1,111,456;1,259,319 respectively at 2026 UVB12,110. Conditional microenterprise exemptions90116/17/18 depend on Law2069 Art. 2§2; they are not a universal zero fee.

Both current matrices identify legal-only4001-36, technical-only4001-37 and combined legal+technical4001-38. Select every actual requested item and provide each block’s evidence for the affected registration. This supports a combined application category, not unlimited grouping of unrelated registrations, holders or products. In the IVD form, adding information does not remove existing approved information: expressly request the intended removal/change as well.

The July 2026 UDI manual says the transition ended8February2026 and reporting is a premarket condition from 9February2026 for authorized MD/IVD being marketed. Report the exact brand, manufacturer, model/reference/presentation and associated UDI-DI consistently with the sanitary registration. Editing a brand in the reporting interface does not approve a registration modification. These sources do not require a new UDI-DI for every internal REF change; identify the issuer-assigned DI and actual device change.

The IVD automatic-modification term is two days following evaluation of the submitted documents, with subsequent review. Decree 581 Art. 6 separately gives30 working days to respond to post-review information requests and then provides suspension/cancellation conditions; neither that cure period nor the 90-working-day initial-registration period is a variation decision term.

Manufacturer name/domicile blocks permit the stated competent-authority evidence or accepted CFS alternative showing the amended details. Actual manufacturer replacement/addition has distinct CFS requirements identifying manufacturer and product/references. Product-name changes have their own supporting CFS provision. Do not infer that every brand/artwork/internal-code change needs a new CFS, or that a holder assignment alone changes the foreign manufacturer.

Decree 581 Art. 5 replacing Decree 3770 Art. 19 provides automatic IVD-registration modifications within two days after evaluation of the submitted documents, followed by review. The applicant must demonstrate no effect on safety or effectiveness and submit the INVIMA form with supporting technical/legal documents. Basic-composition changes, reformulations or changes to initially approved product characteristics require a new registration. Later noncompliance can lead to suspension and cancellation under Art. 6.

The adopted2026 tariff lists automatic MD/IVD legal modification4001-36 at 71.55 UVB, technical4001-37 at 91.78 UVB, and combined legal/technical4001-38 at 103.99 UVB. The captured official workbook (historically acquired as V5) gives COP866,471;1,111,456;1,259,319 respectively at 2026 UVB12,110. Conditional microenterprise exemptions90116/17/18 depend on Law2069 Art. 2§2; they are not a universal zero fee.

The July 2026 UDI manual says the transition ended8February2026 and reporting is a premarket condition from 9February2026 for authorized MD/IVD being marketed. Report the exact brand, manufacturer, model/reference/presentation and associated UDI-DI consistently with the sanitary registration. Editing a brand in the reporting interface does not approve a registration modification. These sources do not require a new UDI-DI for every internal REF change; identify the issuer-assigned DI and actual device change.

The current modification matrix treats manufacturer corporate-name change as legal modification4001-36. For a foreign company, provide competent-origin-authority existence/name evidence, rather than a self-issued company document, or the accepted CFS showing the amended details with the required manufacturer declaration where stated. Submit labels reflecting the new manufacturer name and any applicable updated insert; do not introduce other unrequested label changes.

The current manufacturer-domicile block is legal modification4001-36 and requires origin-authority/company evidence or an accepted CFS reflecting the changed address, plus labels and applicable inserts showing the new domicile. The IVD address block also lists quality/sanitary certificate evidence; retain that requirement for the actual manufacturer arrangement rather than assuming an office move is a plant relocation.

The holder-change block is legal modification4001-36. The assignment/acceptance may be one jointly signed document or separate consent and acceptance documents, signed by the legal representatives of assignor and assignee. Identify registration, expediente, product and brand where relevant, and provide the manufacturer/authorized party’s document establishing its relationship with the assignee. A local holder assignment is distinct from replacing a foreign manufacturer.

The current manufacturer-change/addition block requires evidence that the authorized product characteristics remain unchanged, the new manufacturer’s competent-authority/QMS evidence, CFS identifying the manufacturer and product/references where applicable, updated labels/inserts, and a documented relationship between approved and new manufacturers, such as the specified manufacturing agreement, group-company proof or CFS naming the legal manufacturer and plant. It is not satisfied by a same-person name letter alone.

FM006v13 expressly lists change, addition or exclusion of references in the technical4001-37 K/K1/K2 block. Supply the updated insert/labels and justification requested by that block, with exact old/new details. The supporting text itself repeats presentation wording; it must not be silently rewritten into a different legal test. An order code matters only when it maps to the authorized reference/presentation.

FM006v13 places brand addition/change/exclusion under legal4001-36, with revised labels and insert, trademark status and third-party use permission where relevant, and manufacturer authorization where the brand is not the manufacturer’s. The exclusion justification may be entered in observations as stated. Do not import the logo/barcode/color exemption from older FM006v12 into this current matrix.

The IVD automatic-modification term is two days following evaluation of the submitted documents, with subsequent review. Decree 581 Art. 6 separately gives30 working days to respond to post-review information requests and then provides suspension/cancellation conditions; neither that cure period nor the 90-working-day initial-registration period is a variation decision term.

Manufacturer name/domicile blocks permit the stated competent-authority evidence or accepted CFS alternative showing the amended details. Actual manufacturer replacement/addition has distinct CFS requirements identifying manufacturer and product/references. Product-name changes have their own supporting CFS provision. Do not infer that every brand/artwork/internal-code change needs a new CFS, or that a holder assignment alone changes the foreign manufacturer.