INVIMA rules and guidance for medical device market access, registration, and lifecycle compliance. Each code opens a metadata page with the official source and readable HTML when available.
| Code | Regulation | Category | Effective | Provenance |
|---|---|---|---|---|
| Resolución 2025067543 | 2026 fee resolution — selected medical-device and IVD provisions Complete49-page official original retained; fullphysicalpages1,35,49projected for2026medical-device/IVDvariation tariffs and commencement. All3selected legal bodies visually transcribed against scans, including completep35table withUVBcolumn andconditionalmicroenterpriseexemptions. Other-sector rows remain as original context and do not become device requirements. Full-page images retain source layout, signatures and graphic contactfooters. NoCOPconversion or universal variationroute inferred. | Registration | January 1, 2026 | Official |
| Resolución 1405/2022 | UDI and Semantic Reporting Requirements for Medical Devices Establishes semantic standard and UDI-DI coding requirements for medical devices. Recognizes codes from GS1, HIBCC, ICCBBA, IFA. Transition periods by risk class until 2026. | UDI | February 8, 2024 | Official |
| Decreto 334/2022 | Health Registration Renewal and Advertising Requirements Provisions for renewal, modification, and suspension of health registrations. All advertising must be consistent with conditions approved in health registration. | Registration | January 2024 | Official |
| Resolución 214/2022 | Custom Oral Medical Devices and Dental Laboratories Sanitary requirements for custom-made oral medical devices and the establishments that manufacture, repair, dispense, or adapt them. Adopts verification guides. | GMP/QMS | February 15, 2022 | Official |
| Decreto 1036/2018 | Orphan, Research and Laboratory IVD Reagents Import and commercialization rules for orphan IVDs, research-use reagents, analyte-specific reagents, and general laboratory in vitro reagents not fully covered by Decreto 3770/2004. | Registration | June 21, 2018 | Official |
| Resolución 5491/2017 | Custom Hearing-Aid Medical Devices Requirements for custom-made hearing-aid devices and the establishments that manufacture, assemble, repair, dispense, or adapt them. | GMP/QMS | January 17, 2018 | Official |
| Decreto 581/2017 | Amendments to IVD Registration and Renewal Modifies Decreto 3770/2004. Updates automatic sanitary-registration and renewal rules for Category I and II in vitro diagnostic reagents. | Registration | April 4, 2017 | Official |
| Decreto 582/2017 | Simplified Registration Renewal for Medical Devices Allows automatic renewal of Marketing Authorization if labeling and manufacturing processes have not been amended. Simplifies registration procedures. | Registration | April 4, 2017 | Official |
| Resolución 2968/2015 | Custom External Orthopedic Medical Devices Sanitary requirements for establishments that make and adapt custom-made external orthopedic medical devices. | GMP/QMS | August 14, 2015 | Official |
| Decreto 3275/2009 | Modification to Medical Device Registration Requirements Modifies Article 1 and adds a paragraph to Article 18 in Decreto 4725/2005, updating requirements for medical device registration and biomedical equipment spare parts. | Registration | August 28, 2009 | Official |
| Resolución 4816/2008 | National Technovigilance Program Establishes Colombia's National Technovigilance Program for post-market surveillance. Defines adverse event reporting requirements, timelines, and responsibilities. | Vigilance | November 27, 2008 | Official |
| Resolución 4396/2008 | Technical Sanitary Conditions for Medical Device Manufacturing Adopts the manual of technical sanitary conditions for establishments that manufacture custom-made medical devices for visual and ocular health. | GMP/QMS | November 12, 2008 | Official |
| Resolución 4002/2007 | Storage and Conditioning Requirements for Medical Devices Adopts the Manual of Storage and Conditioning Capacity Requirements for Medical Devices. Establishes conditions for proper storage facilities. | GMP/QMS | November 2, 2007 | Official |
| Decreto 1030/2007 | Technical Requirements for Custom Medical Devices Technical sanitary requirements for custom-made medical devices for visual and ocular health, and establishments that manufacture and commercialize them. | GMP/QMS | March 30, 2007 | Official |
| Decreto 4725/2005 | Medical Device Registration and Surveillance Regime Core regulation for medical device sanitary registration, commercialization permits, and surveillance in Colombia. Defines risk classification (Class I, IIa, IIb, III) and registration pathways. | Registration | December 26, 2005 | Official |
| Decreto 3770/2004 | In Vitro Diagnostic Medical Devices Registration Regulatory framework for in vitro diagnostic (IVD) medical devices in Colombia. Establishes IVD classification into Categories I, II, and III based on risk. | Registration | November 16, 2004 | Official |
| Decreto 4725/2005 — complete original expression | Decreto 4725 de 2005 — complete agency-hosted original text (31 pages) Complete 31-page original-text publication of Decreto 4725 de 2005 hosted by INVIMA. This is a separate complete source expression of the same decree represented by the existing Decreto 4725/2005 article view; it is not a new legal instrument. The original cover and closing print 26 December 2005. The full text retains all 90 articles and the printed closing names, including the publisher’s first-page “Hoja 1 de 1” and repeated “4125” running-header artifacts. Article 1 expressly excludes custom-made devices and in vitro diagnostic reagents from this decree’s scope. The existing article view is retained separately. Original page images govern the unchanged native search layer, including image-only lettering and source extraction artifacts. This captured original text is not a current consolidated edition, a signed Gazette facsimile, or verification of current fees, clocks or change-question answers. | Registration | — | Official |
| Decreto581/2017 — INVIMA compiled expression | Decreto581 de2017 — complete INVIMA-hosted compiled expression Complete five-page INVIMA-hosted editorial compilation of Decree581/2017. It preserves amendment, quoted IVD modification provision, subsequent-review conditions and closing publication text. Government hosting does not make it a signed Gazette facsimile. Separate from the legacy SHA-less Spanish HTML projection, whose identity and anchors remain untouched; no present consolidated-law or question-completion assertion. | Registration | — | Official |
| Decreto 582/2017 — INVIMA compiled expression (2021) | Decreto 582 de 2017 — complete INVIMA-hosted Normograma compilation (2021 print) Complete five-page INVIMA-hosted Normograma print of Decreto 582 de 2017, retaining all six outer articles, quoted replacement provisions, 2018 doctrine concordances, printed closing names and the complete editorial footer. This is a separate source expression of the same amending decree represented by the existing Decreto 582/2017 article view; it adds no new legal instrument and keeps that view separately available. The final page credits Avance Jurídico Casa Editorial Ltda. and prints an editorial last update of 17 December 2021. The 2018 concordances and editorial layer are preserved as published; this is not the original signed Gazette facsimile or a certified 2026 consolidated text. The amendment concerns medical devices under Decreto 4725/2005 and is not extended automatically to the separate IVD regime. Original page images govern the unchanged native search layer. No current fee, clock, factual conclusion or change-question outcome is established by preserving this edition. | Registration | — | Official |
| Decreto 582/2017 — signed scan expression | Decreto 582 de 2017 — complete agency-hosted signed decree scan (4 pages) Complete four-page signed executive-decree scan of Decreto 582 de 2017 hosted by INVIMA, with the 4 April 2017 stamps, all six outer articles, closing and visible handwritten signatures. This is a source expression of the same decree shown in the existing Decreto 582/2017 article view, not a new legal instrument. It is distinct from the separately captured five-page Normograma print with editorial concordances and retains the signed scan without that later editorial layer. The existing article view and its references remain separately available. Complete page images govern the embedded publisher search text, which contains evident scan/OCR recognition errors and is preserved unchanged rather than presented as a verified transcription. No Gazette-page facsimile, current consolidated edition, current fee, review-clock or change-question outcome is certified. The device amendment is not applied automatically to the separate IVD regime. | Registration | — | Official |
| INVIMA device form-completion booklet (2025) | Instructivo de diligenciamiento —dispositivos médicos y equipos biomédicos, 2025 Complete 52-page official INVIMA form-completion booklet with 2025 printed on the cover and credits. This captured guide covers medical devices, biomedical equipment, renewals and automatic modifications, retaining all original form illustrations, sections and reference-country appendix. The official medical-device page links the booklet landing page, whose observed preview route returned this complete PDF. Original page images govern the unchanged native search layer, including column and form-example extraction artifacts; native text is not a verified transcription. This procedural companion does not by itself establish complete current legal modification requirements, apply automatically to the separate IVD regime, certify current fees or complete any question. Source-only preservation; no facts, fees, timing, bindings or question status changes. | Registration | — | Official |
| INVIMA 2022 device form-completion booklet | Cartilla para el correcto diligenciamiento de los formularios de registro sanitario, permiso de comercialización, renovación y modificación de dispositivos médicos y equipos biomédicos —2022 Complete76-page official INVIMA2022 booklet on registration, commercialization permits, renewal and modification forms for medical devices and biomedical equipment. It retains definitions, all modification-specific matrices and conditional supporting documents, form examples, annexes and country/authority reference tables. All original page images govern the unchanged native search layer, including source layout or extraction artifacts; native text is not a verified transcription. This device booklet does not automatically apply to the separate IVD regime or establish current2026 form versions, fees, clocks or any answered-question outcome. Source-only preservation; no facts, fee values, timing, bindings or question-completion status changes. | Registration | — | Official |
| ASS-RSA-FM006, versión 13 | Formato único de diligenciamiento de reactivos de diagnóstico in vitro — versión 13, libro Excel original completo Complete official XLSX form workbook captured on 21 October 2026 (11 worksheets; four original controls). The source header prints an emission date of 6 November 2025; this is not asserted as a legal publication or effective date. The original XLSX is authoritative. Its read-only projection includes all worksheets, including hidden data, literal formulas and separately labelled stored values, complete original XML/relationships/control attributes, embedded original images and uninterpreted binary parts. This projection is not a facsimile, a printed-page reproduction, a completed application or a current-requirements determination; no formula, control, macro or external relationship is executed. Other versions and the older form-completion instruction expression remain separate. | Registration | — | Official |
| ASS-RSA-FM006 | Instructivo para el diligenciamiento de los formularios de reactivos de diagnóstico in vitro — versión10 Complete one-page image-only official INVIMA form-completion instruction, codeASS-RSA-FM006, version10, printed emission2023-07-28. All thirteen numbered instructions, notes, original layout and institutional header are retained in the authoritative image. Native PDF text is empty; no OCR or invented transcription is supplied. The historical form version, stated submission methods and source timelines are not established as current2026 requirements or a substitute for the later version13 workbook. Source-only preservation; no facts, fee values, timing, bindings or question-completion status changes. | Registration | — | Official |
| ASS-RSA-FM007, versión 17 | Formato único de diligenciamiento de dispositivos médicos — versión 17, libro Excel original completo Complete official XLSX form workbook captured on 21 October 2026 (18 worksheets; 88 original controls). The source header prints an emission date of 6 November 2025; this is not asserted as a legal publication or effective date. The original XLSX is authoritative. Its read-only projection includes all worksheets, including hidden data, literal formulas and separately labelled stored values, complete original XML/relationships/control attributes, embedded original images and uninterpreted binary parts. This projection is not a facsimile, a printed-page reproduction, a completed application or a current-requirements determination; no formula, control, macro or external relationship is executed. The original invalid print-title definition #N/A is retained without repair. Other versions and the older form-completion instruction expression remain separate. | Registration | — | Official |
Exports carry source + retrieval dateSource-linked rules for common changes to a registered medical device. Read the scope and conditions with each rule; unverified details are listed separately.
A change to the registered brand name and a change to logo artwork can follow different rules. The legal manufacturer, device design and intended purpose remain the same.
Verified guidance on
Read each rule with its scope and conditions.
Modification requests for registros sanitarios and permisos de comercialización are processed automatically, within the 2-day term of Art. 22(b) and with later document review; INVIMA approves modifications demonstrated not to affect the device's safety and effectiveness.
An existing registration or marketing permit cannot be modified when a significant change may affect safety and effectiveness, or when the modification involves changes in design, chemical composition of materials, energy source or manufacturing processes.
Baseline fact confirmed; article now bears the text substituted by Decreto 582 de 2017.
FM007 v17 places brand addition, change and exclusion in the technical 4001-37 matrix. Its U1/U2/U3 block requires the exact current/proposed resolution wording and the manufacturer’s original labels showing the changed or added brand. This MD block does not itself list the trademark-status, third-party brand-use permission or manufacturer brand-use permission documents that are expressly listed in the separate IVD FM006 v13 G block. Distinguish actual registered-brand changes from artwork; this matrix does not establish a universal logo-only exemption.
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.
Decree 582 Art. 2 replacing Decree 4725 Art. 30 applies the Art. 22(b) two-day term following evaluation of the submitted documents, with later review. It is not a universal two-day period from upload or a deadline for resolving a significant-change/new-registration application.
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 same legal manufacturer changes its name, potentially alongside the device brand. A transfer to another legal entity is a separate question; permission to combine filings needs its own evidence.
Verified guidance on
Read each rule with its scope and conditions.
Modification requests for registros sanitarios and permisos de comercialización are processed automatically, within the 2-day term of Art. 22(b) and with later document review; INVIMA approves modifications demonstrated not to affect the device's safety and effectiveness.
An existing registration or marketing permit cannot be modified when a significant change may affect safety and effectiveness, or when the modification involves changes in design, chemical composition of materials, energy source or manufacturing processes.
Baseline fact confirmed; article now bears the text substituted by Decreto 582 de 2017.
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.
Package labels must carry, at minimum, in Spanish: product name; lot or serial number; expiry date when applicable; registro sanitario or permiso number; manufacturer and/or importer with address; and special legends such as 'estéril', 'usar solo una vez'.
The brief's hint of 'Resolución 3100 de 2019' for labeling is incorrect: that resolution governs habilitación of health-services providers (IPS).
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.
Decree 582 Art. 2 replacing Decree 4725 Art. 30 applies the Art. 22(b) two-day term following evaluation of the submitted documents, with later review. It is not a universal two-day period from upload or a deadline for resolving a significant-change/new-registration application.
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.
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. Reference addition has its own CFS supporting 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.
An office address change for the same legal entity, potentially alongside name and brand changes. This does not cover moving a factory or manufacturing site, and a combined filing cannot be assumed.
Verified guidance on
Read each rule with its scope and conditions.
Modification requests for registros sanitarios and permisos de comercialización are processed automatically, within the 2-day term of Art. 22(b) and with later document review; INVIMA approves modifications demonstrated not to affect the device's safety and effectiveness.
An existing registration or marketing permit cannot be modified when a significant change may affect safety and effectiveness, or when the modification involves changes in design, chemical composition of materials, energy source or manufacturing processes.
Baseline fact confirmed; article now bears the text substituted by Decreto 582 de 2017.
The current MD manufacturer-domicile block is legal modification 4001-36. It requires the stated competent-origin-authority evidence or the accepted CFS alternative reflecting the changed company address with the specified manufacturer/holder declaration. Provide manufacturer labels showing the new address. The separate storage/conditioning-capacity certificate row applies to importer or conditioner domicile changes; it must not be imposed on an overseas manufacturer’s office update merely because the word address changes.
Package labels must carry, at minimum, in Spanish: product name; lot or serial number; expiry date when applicable; registro sanitario or permiso number; manufacturer and/or importer with address; and special legends such as 'estéril', 'usar solo una vez'.
The brief's hint of 'Resolución 3100 de 2019' for labeling is incorrect: that resolution governs habilitación of health-services providers (IPS).
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.
Decree 582 Art. 2 replacing Decree 4725 Art. 30 applies the Art. 22(b) two-day term following evaluation of the submitted documents, with later review. It is not a universal two-day period from upload or a deadline for resolving a significant-change/new-registration application.
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.
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. Reference addition has its own CFS supporting 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.
Check which identifier actually changes. A commercial catalogue, REF or order code is not automatically a device model, registered identifier, GTIN or UDI-DI. Rules for one identifier do not establish the route for another.
Verified guidance on
Read each rule with its scope and conditions.
Modification requests for registros sanitarios and permisos de comercialización are processed automatically, within the 2-day term of Art. 22(b) and with later document review; INVIMA approves modifications demonstrated not to affect the device's safety and effectiveness.
An existing registration or marketing permit cannot be modified when a significant change may affect safety and effectiveness, or when the modification involves changes in design, chemical composition of materials, energy source or manufacturing processes.
Baseline fact confirmed; article now bears the text substituted by Decreto 582 de 2017.
FM007v17 Y1/Y2 explicitly covers adding/excluding references with the required technical comparison, CFS and catalogue/test/label support. The form requires exact current-versus-requested resolution text. It does not expressly name a pure internal REF rename: determine whether the order code is an authorized reference/model, an added/excluded product or only an internal identifier before selecting this route.
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.
Decree 582 Art. 2 replacing Decree 4725 Art. 30 applies the Art. 22(b) two-day term following evaluation of the submitted documents, with later review. It is not a universal two-day period from upload or a deadline for resolving a significant-change/new-registration application.
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.
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. Reference addition has its own CFS supporting 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.
A real change of legal manufacturer, registration holder or owner. This differs from renaming the same entity; a change of local representative or importer alone does not establish a registration transfer route. Where other changes occur with the transfer, the exact combination and sequence need separate evidence.
Verified guidance on
Read each rule with its scope and conditions.
Modification requests for registros sanitarios and permisos de comercialización are processed automatically, within the 2-day term of Art. 22(b) and with later document review; INVIMA approves modifications demonstrated not to affect the device's safety and effectiveness.
An existing registration or marketing permit cannot be modified when a significant change may affect safety and effectiveness, or when the modification involves changes in design, chemical composition of materials, energy source or manufacturing processes.
Baseline fact confirmed; article now bears the text substituted by Decreto 582 de 2017.
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.
Decree 582 Art. 2 replacing Decree 4725 Art. 30 applies the Art. 22(b) two-day term following evaluation of the submitted documents, with later review. It is not a universal two-day period from upload or a deadline for resolving a significant-change/new-registration application.
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.
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. Reference addition has its own CFS supporting 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.
Changes to brand, manufacturer name, office address and reference codes may occur together, including with a real transfer to another legal manufacturer, registration holder or owner. Assess transfer with each single change, and transfer with brand plus reference, manufacturer name plus reference, or office address plus reference changes: seven transfer combinations in total. Evidence must establish the exact combination and the order of filings and approvals. These combinations and their sequence are not all verified by the rules below; a rule for one change does not prove that a single application, fee or review period covers the combination.
Verified guidance on
Read each rule with its scope and conditions.
Modification requests for registros sanitarios and permisos de comercialización are processed automatically, within the 2-day term of Art. 22(b) and with later document review; INVIMA approves modifications demonstrated not to affect the device's safety and effectiveness.
An existing registration or marketing permit cannot be modified when a significant change may affect safety and effectiveness, or when the modification involves changes in design, chemical composition of materials, energy source or manufacturing processes.
Baseline fact confirmed; article now bears the text substituted by Decreto 582 de 2017.
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 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 MD manufacturer-domicile block is legal modification 4001-36. It requires the stated competent-origin-authority evidence or the accepted CFS alternative reflecting the changed company address with the specified manufacturer/holder declaration. Provide manufacturer labels showing the new address. The separate storage/conditioning-capacity certificate row applies to importer or conditioner domicile changes; it must not be imposed on an overseas manufacturer’s office update merely because the word address changes.
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.
FM007v17 Y1/Y2 explicitly covers adding/excluding references with the required technical comparison, CFS and catalogue/test/label support. The form requires exact current-versus-requested resolution text. It does not expressly name a pure internal REF rename: determine whether the order code is an authorized reference/model, an added/excluded product or only an internal identifier before selecting this route.
FM007 v17 places brand addition, change and exclusion in the technical 4001-37 matrix. Its U1/U2/U3 block requires the exact current/proposed resolution wording and the manufacturer’s original labels showing the changed or added brand. This MD block does not itself list the trademark-status, third-party brand-use permission or manufacturer brand-use permission documents that are expressly listed in the separate IVD FM006 v13 G block. Distinguish actual registered-brand changes from artwork; this matrix does not establish a universal logo-only exemption.
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.
Decree 582 Art. 2 replacing Decree 4725 Art. 30 applies the Art. 22(b) two-day term following evaluation of the submitted documents, with later review. It is not a universal two-day period from upload or a deadline for resolving a significant-change/new-registration application.
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.
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. Reference addition has its own CFS supporting 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.
Each row above represents one regulatory instrument. Its code is the authority’s identifier. A regulation page collects the metadata and official source; when readable HTML is available, article links can open and highlight the exact cited passage.
Keep Colombia as the target market while you move into registration records, classification, cross-country product research, or pathway planning.
Check a preliminary INVIMA risk class.
Inspect public INVIMA records.
Search the same product in multiple country registries.
Estimate pathway, government fees, preparation, and review time.
Structure company, product, model, approval, and evidence facts once.
Compare existing evidence against Colombia needs.
Connect route, evidence, labels, representatives, and launch dependencies.
Test a current INVIMA update against one product and its evidence.
