Pure Global AI
INVIMA · structured requirements

🇨🇴 Colombia IVD regulatory data

Explore the IVD requirements currently available for Colombia, organized by topic and linked to official sources.

15 facts7 dimensions9 official sourceslatest verification 2026-10-21

Changes after registration

Explore questions and sources →

Common questions about changing a registered IVD in Colombia. Each question separates published rules from details still awaiting verification.

Change control

Does the event require internal documentation, notice, prior approval, transfer, or a new application?

Compare countries

Actual manufacturer replacement has its own evidence block

changes.actual-manufacturer-replacement-ivd
Fact-level verified

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.

Conditions
  • A significant MD change or a reformulated/initial-characteristic IVD change is outside the automatic-modification route.

The current forms recognize a combined legal/technical request

changes.combined-modification-matrix
Fact-level verified

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.

ASS-RSA-FM006v13/06Nov2025 current biblioteca attachment

A holder assignment requires both parties and manufacturer linkage

changes.holder-assignment-materials-ivd
Fact-level verified

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.

IVD modifications are conditional automatic decisions

changes.ivd-automatic-modification
Fact-level verified

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.

IVD change/addition/exclusion of references is expressly listed

changes.ivd-reference-change-materials
Fact-level verified

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.

Manufacturer domicile is a legal modification with supporting evidence

changes.manufacturer-office-address-materials-ivd
Fact-level verified

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.

Conditions
  • Identify whether the field is legal-manufacturer commercial domicile, actual manufacturing site, importer or conditioner. A production/process change requires separate assessment.

Same-person manufacturer name is a legal modification

changes.same-person-name-materials-ivd
Fact-level verified

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.

Conditions
  • The legal person remains the same. Actual manufacturer replacement and holder assignment use separate blocks.

Fees

What regulator fee applies to this class, route, event, and date?

Compare countries

The 2026 tariff distinguishes legal, technical and combined modifications

changes.modification-tariff-2026
Fact-level verified

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.

Conditions
  • Use the actual change type: MD brand is technical whereas IVD brand is legal. The amounts are per applicable tariff event, not a worldwide portfolio quote.
Official2026 tariff manual version5 complete workbookASS-RSA-FM007v17/06Nov2025 current biblioteca attachmentASS-RSA-FM006v13/06Nov2025 current biblioteca attachment

Label, IFU & language

Which label and IFU elements, languages, symbols, and translation controls apply?

Compare countries

A renewal stock opinion is not a general variation grace

changes.renewal-stock-opinion-boundary
Fact-level verified

INVIMA Concept187/2021 addresses renewal: finished stock already manufactured/imported in Colombia before renewal may exhaust through useful life, whereas new imports/manufacture use the renewed number and old unused packaging is treated differently. It is a bounded legal opinion and does not grant an automatic name/brand/manufacturer-change stock period. Use the actual variation decision and the affected lots, dates, expiry and location before relying on a stock plan.

Official forms & portals

Which current form, portal, account, and submission package must be used?

Compare countries

CFS depends on the actual modification block

changes.change-cfs-evidence-ivd
Fact-level verified

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.

Conditions
  • Use the selected row’s issuance, validity, translation and legalization conditions. The legal person, product and reference mapping must be established.

Reliance & recognition

Which foreign decisions or evidence can be reused, with what effect and conditions?

Compare countries

Existing records include acceptance, restrictions and evidence reuse. The applicable product scope and conditions are preserved below; a reference does not by itself confer market access.

Colombia approvals and evidence in other markets (0 records)

No linked record is currently maintained. This does not establish that a pathway is unavailable.

Prior approvals and evidence for Colombia (11 records)

ColombiaUS FDA

Prior approval / evidence record

FDA 510(k)

Authority

FDA 510(k)

Accepted

Yes

Benefit

Reference-country origin under Decreto 3275/2009, homologating technical studies, sterilisation method and disposal method for Class I/IIa and additionally clinical studies for Class IIb

Timeline Savings

None published

Decreto 4725 de 2005 — INVIMA statutory review clocks (Arts. 21-22)INVIMA medical devices and biomedical equipment procedures — Formato Único numerals by risk class and the Decreto 3275/2009 homologation for reference countries

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

ColombiaUS FDA · EU conformity assessment · Australia TGA · Health Canada · Japan MHLW / PMDA

Prior approval / evidence record

Class IIa

Id

class-iia

Class Name

Class IIa

Risk Level

medium

Pathway

Registration (NSO)

Official Timeline
Min

2

Max

2

Unit

working-days

Verification Status

official-verified

Official Source
Title

Decreto 4725 de 2005 — INVIMA statutory review clocks (Arts. 21-22)

Url

https://normograma.invima.gov.co/normograma/compilacion/docs/decreto_4725_2005.htm

Accessed Date

2026-08-25

Realistic Timeline
Min

1

Max

2

Unit

months

With Prior Approval
Min

2

Max

3

Unit

months

Prior Approval Benefits
  • EU CE Mark
  • FDA
  • Health Canada
  • Japan MHLW
  • Australia TGA
Notes
  • Decreto 4725/2005 Arts. 21-22: automatic registro administrative act within 2 working days once documents are complete (Classes I and IIa)
  • Reliance pathway available for recognized approvals
Clinical Trial Required

No

Local Testing Required

No

Gmp Required

Yes

Decreto 4725 de 2005 — INVIMA statutory review clocks (Arts. 21-22)

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

ColombiaUS FDA · EU conformity assessment · Australia TGA · Health Canada · Japan MHLW / PMDA

Prior approval / evidence record

Class IIb

Id

class-iib

Class Name

Class IIb

Risk Level

high

Pathway

Registration (RSO)

Official Timeline
Min

90

Max

90

Unit

working-days

Verification Status

official-verified

Official Source
Title

Decreto 4725 de 2005 — INVIMA statutory review clocks (Arts. 21-22)

Url

https://normograma.invima.gov.co/normograma/compilacion/docs/decreto_4725_2005.htm

Accessed Date

2026-08-25

Realistic Timeline
Min

6

Max

12

Unit

months

With Prior Approval
Min

4

Max

6

Unit

months

Prior Approval Benefits
  • EU CE Mark
  • FDA
  • Health Canada
  • Japan MHLW
  • Australia TGA
Notes
  • Decreto 4725/2005: 90 working days for registro sanitario evaluation once documents are complete (Classes IIb and III)
  • Incomplete dossiers are rejected at filing (not suspended)
  • Technical documentation review required
Clinical Trial Required

No

Local Testing Required

No

Gmp Required

Yes

Decreto 4725 de 2005 — INVIMA statutory review clocks (Arts. 21-22)

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

ColombiaNMPA

Prior approval / evidence record

China NMPA approval: origin evidence only

reliance.china-nmpa-origin-evidence
Pending verification
Statement

For imported devices, Decreto 4725/2005 Art. 29 b) requires a certification from the competent authority of the country of origin stating that the product is authorized for production or marketing there; for China-made devices the NMPA registration certificate or filing record fulfils this requirement. The full INVIMA dossier (technical studies, sterilization, clinical evidence) still applies because China is not a reference country.

Source Jurisdiction Id

china

Source Authority Id

nmpa

Source Approval

China NMPA medical device registration certificate (Class II/III) or Class I filing record

Target Jurisdiction Id

colombia

China Classes In Scope

NMPA Class I filings and Class II/III certificates for all INVIMA classes of imported devices

Edge Type

Origin Country Evidence

Market Access Strength

Evidence Only

Regulatory Layer

Product Marketing

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • Document must come from the competent authority of the country of origin (manufacture)
  • If the device is not used in the country of origin, a CLV from a reference country or MRA country is additionally required
  • Independent verification is incomplete. Treat this record as a research lead, not a confirmed benefit or exclusion; see the 2026-09-15 independent review.

Effective from 2005-12-27

Source passage: b) Certificación de la autoridad competente del país de origen en el que conste que el producto ha sido autorizado para su producción o comercialización en el territorio del país de origen.

ColombiaBrazil ANVISA

Prior approval / evidence record

ANVISA (Brazil)

Authority

ANVISA (Brazil)

Accepted

No

Benefit

Brazil is not on the INVIMA reference-country list and there is no device mutual recognition agreement in force

Timeline Savings

None

Decreto 4725 de 2005 — INVIMA statutory review clocks (Arts. 21-22)INVIMA medical devices and biomedical equipment procedures — Formato Único numerals by risk class and the Decreto 3275/2009 homologation for reference countries

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

ColombiaUS FDA · Australia TGA · Health Canada · Japan MHLW / PMDA

Prior approval / evidence record

Homologación for reference countries (Decreto 3275/2009)

Name

Homologación for reference countries (Decreto 3275/2009)

Description

Colombia does not run a separate reliance queue. What a reference-country approval buys is the right to skip specific numerals of the Formato Único: for Class I and IIa the technical studies and analytical checks, the sterilisation method and the disposal method; for Class IIb those three plus the clinical studies. Class III is outside the homologation and has to file all twenty numerals.

Timeline Reduction

None — the Decreto 4725/2005 clocks are unchanged; the saving is in dossier assembly

Eligibility
  • Device originates from a reference country: the European Community, the United States, Canada, Japan, Australia, or a country with a mutual recognition agreement
  • Risk class I, IIa or IIb — Class III devices file the complete Formato Único regardless of origin
Decreto 4725 de 2005 — INVIMA statutory review clocks (Arts. 21-22)INVIMA medical devices and biomedical equipment procedures — Formato Único numerals by risk class and the Decreto 3275/2009 homologation for reference countries

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

ColombiaNMPA

Regulatory reference

China NMPA approval: not reference

reliance.china-nmpa-not-reference
Pending verification
Statement

Decreto 4725/2005 Art. 29 b) names the 'países de referencia' exhaustively as the European Economic Community, the United States, Canada, Japan and Australia (plus countries with a mutual recognition agreement), and Decreto 3275/2009 (Art. 18 parágrafo 3) lets a free-sale certificate from those reference countries stand in for technical studies, sterilization and clinical data for class I, IIa and IIb devices. China is not a reference country and Colombia has no mutual-recognition agreement with it, so an NMPA certificate cannot replace technical evidence.

Source Jurisdiction Id

china

Source Authority Id

nmpa

Source Approval

China NMPA medical device registration certificate (Class II/III) or Class I filing record

Target Jurisdiction Id

colombia

China Classes In Scope

NMPA Class I/II/III; target INVIMA classes I, IIa, IIb (Decreto 3275/2009 homologation) and reference-country CLV substitution under Art. 29 b)

Edge Type

No Reliance Route

Market Access Strength

none

Regulatory Layer

Product Marketing

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • Reference countries: Comunidad Económica Europea, Estados Unidos, Canadá, Japón, Australia, or countries with a mutual recognition agreement (Art. 29 b)
  • Decreto 3275/2009 homologation applies only to non-controlled-technology devices of class I, IIa and IIb and only for CLVs from reference countries
  • Independent verification is incomplete. Treat this record as a research lead, not a confirmed benefit or exclusion; see the 2026-09-15 independent review.

Effective from 2005-12-27

Source passage: el certificado de la entidad sanitaria que conste que se vende libremente en un país de referencia (Comunidad Económica Europea, Estados Unidos de Norte América, Canadá, Japón y Australia), o con los países en donde exista acuerdo de mutuo reconocimiento

Review clocks

What review, validation, and applicant stop-clock rules apply?

Compare countries

The IVD two-day term follows documentary evaluation

changes.ivd-automatic-clock-trigger
Fact-level verified

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.

UDI, listing & traceability

Which UDI, device listing, database, and traceability duties apply?

Compare countries

Registration changes and UDI data updates are separate acts

changes.udi-data-after-change
Fact-level verified

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.

Current UDI reporting instructivo version6 July2026 actualPDF

Related structured datasets

Classification systems · 1 record
Open Risk classes I, IIa, IIb and III (Decreto 4725 de 2005) plus IVD categories I-III (Decreto 3770 de 2004). →
Id

colombia:medical-device

Jurisdiction Id

colombia

Domains
  • medical-device
  • ivd
Name

Risk classes I, IIa, IIb and III (Decreto 4725 de 2005) plus IVD categories I-III (Decreto 3770 de 2004).

Classes
  • Id

    i

    Label

    Class I

    Normalized Risk Level

    low

  • Id

    ii

    Label

    Class II

    Normalized Risk Level

    medium

  • Id

    iia

    Label

    Class IIa

    Normalized Risk Level

    medium

  • Id

    iib

    Label

    Class IIb

    Normalized Risk Level

    high

  • Id

    iii

    Label

    Class III

    Normalized Risk Level

    highest

Regulator

INVIMA

Official Domains
  • invima.gov.co
  • normograma.invima.gov.co
Source Status

official-source-verified

Source Title

Decreto 4725 de 2005, Arts. 5-7 (clasificación por el fabricante; 18 reglas)

Source Url

https://normograma.invima.gov.co/normograma/compilacion/docs/decreto_4725_2005.htm

Verified On

2026-08-25

Source Supports
  • class-axis
  • classification-rules
Notes
  • Decreto 4725 de 2005 Arts. 5-7: classification is made by the manufacturer based on potential risks of use and failure (criteria: contact duration, invasiveness, local vs systemic effect) applying the 18 rules of Art. 7 - general-device classes I (low), IIa (moderate), IIb (high), III (very high).
  • Class II (plain) is the Decreto 3770 de 2004 IVD category: IVDs (diagnostic reagents) classify into categories I-III by sanitary risk (Art. 3; registro for category III per Art. 8, automatic for I-II per Art. 11). INVIMA registration data uses these categories in the same NIVEL_RIESGO field - every observed "II" value occurs on GRUPO=REACTIVO DIAGNOSTICO rows.
  • Route by class: Class I/IIa non-controlled devices obtain automatic registro (Art. 17); class IIb/III require registro with technical evaluation (Art. 16); controlled biomedical technology (prototypes, used/repotenciado, offer-controlled, >700 SMMLV) requires permiso de comercialización (Arts. 2, 23).
Registration pathways, prior approvals and planning · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Colombia registration →
Country

Colombia

Jurisdiction Id

colombia

Country Code

CO

Flag

🇨🇴

Regulator

Instituto Nacional de Vigilancia de Medicamentos y Alimentos

Regulator Abbrev

INVIMA

Region

americas

Tier

2

Risk Classification

4-class (I, IIa, IIb, III)

Classes
  • Id

    class-i

    Class Name

    Class I

    Risk Level

    low

    Pathway

    Notification (NSO)

    Official Timeline
    Min

    2

    Max

    2

    Unit

    working-days

    Verification Status

    official-verified

    Official Source
    Title

    Decreto 4725 de 2005 — INVIMA statutory review clocks (Arts. 21-22)

    Url

    https://normograma.invima.gov.co/normograma/compilacion/docs/decreto_4725_2005.htm

    Accessed Date

    2026-08-25

    Realistic Timeline
    Min

    1

    Max

    2

    Unit

    months

    Notes
    • Decreto 4725/2005 Arts. 21-22 (as amended by Decreto 582/2017): once documents are complete, INVIMA issues the automatic registro administrative act within 2 working days (Classes I and IIa)
    • Notification-based, minimal review
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    No

  • Id

    class-iia

    Class Name

    Class IIa

    Risk Level

    medium

    Pathway

    Registration (NSO)

    Official Timeline
    Min

    2

    Max

    2

    Unit

    working-days

    Verification Status

    official-verified

    Official Source
    Title

    Decreto 4725 de 2005 — INVIMA statutory review clocks (Arts. 21-22)

    Url

    https://normograma.invima.gov.co/normograma/compilacion/docs/decreto_4725_2005.htm

    Accessed Date

    2026-08-25

    Realistic Timeline
    Min

    1

    Max

    2

    Unit

    months

    With Prior Approval
    Min

    2

    Max

    3

    Unit

    months

    Prior Approval Benefits
    • EU CE Mark
    • FDA
    • Health Canada
    • Japan MHLW
    • Australia TGA
    Notes
    • Decreto 4725/2005 Arts. 21-22: automatic registro administrative act within 2 working days once documents are complete (Classes I and IIa)
    • Reliance pathway available for recognized approvals
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    Yes

  • Id

    class-iib

    Class Name

    Class IIb

    Risk Level

    high

    Pathway

    Registration (RSO)

    Official Timeline
    Min

    90

    Max

    90

    Unit

    working-days

    Verification Status

    official-verified

    Official Source
    Title

    Decreto 4725 de 2005 — INVIMA statutory review clocks (Arts. 21-22)

    Url

    https://normograma.invima.gov.co/normograma/compilacion/docs/decreto_4725_2005.htm

    Accessed Date

    2026-08-25

    Realistic Timeline
    Min

    6

    Max

    12

    Unit

    months

    With Prior Approval
    Min

    4

    Max

    6

    Unit

    months

    Prior Approval Benefits
    • EU CE Mark
    • FDA
    • Health Canada
    • Japan MHLW
    • Australia TGA
    Notes
    • Decreto 4725/2005: 90 working days for registro sanitario evaluation once documents are complete (Classes IIb and III)
    • Incomplete dossiers are rejected at filing (not suspended)
    • Technical documentation review required
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    Yes

  • Id

    class-iii

    Class Name

    Class III

    Risk Level

    highest

    Pathway

    Full Registration (RSO)

    Official Timeline
    Min

    90

    Max

    90

    Unit

    working-days

    Verification Status

    official-verified

    Official Source
    Title

    Decreto 4725 de 2005 — INVIMA statutory review clocks (Arts. 21-22)

    Url

    https://normograma.invima.gov.co/normograma/compilacion/docs/decreto_4725_2005.htm

    Accessed Date

    2026-08-25

    Realistic Timeline
    Min

    9

    Max

    18

    Unit

    months

    Notes
    • Decreto 4725/2005: 90 working days for registro sanitario evaluation once documents are complete (Classes IIb and III)
    • Incomplete dossiers are rejected at filing (not suspended)
    • Clinical evidence mandatory
    • Class III sits outside the Decreto 3275/2009 homologation, so a reference-country approval removes nothing: all twenty numerals of the Formato Único have to be filed whatever the origin
    Clinical Trial Required

    Yes

    Local Testing Required

    No

    Gmp Required

    Yes

Expedited Pathways
  • Name

    Homologación for reference countries (Decreto 3275/2009)

    Description

    Colombia does not run a separate reliance queue. What a reference-country approval buys is the right to skip specific numerals of the Formato Único: for Class I and IIa the technical studies and analytical checks, the sterilisation method and the disposal method; for Class IIb those three plus the clinical studies. Class III is outside the homologation and has to file all twenty numerals.

    Timeline Reduction

    None — the Decreto 4725/2005 clocks are unchanged; the saving is in dossier assembly

    Eligibility
    • Device originates from a reference country: the European Community, the United States, Canada, Japan, Australia, or a country with a mutual recognition agreement
    • Risk class I, IIa or IIb — Class III devices file the complete Formato Único regardless of origin
Prior Approvals
  • Authority

    FDA 510(k)

    Accepted

    Yes

    Benefit

    Reference-country origin under Decreto 3275/2009, homologating technical studies, sterilisation method and disposal method for Class I/IIa and additionally clinical studies for Class IIb

    Timeline Savings

    None published

  • Authority

    EU CE Mark

    Accepted

    Yes

    Benefit

    Reference-country origin under Decreto 3275/2009

    Timeline Savings

    None published

  • Authority

    Health Canada

    Accepted

    Yes

    Benefit

    Reference-country origin under Decreto 3275/2009

    Timeline Savings

    None published

  • Authority

    Japan MHLW

    Accepted

    Yes

    Benefit

    Reference-country origin under Decreto 3275/2009

    Timeline Savings

    None published

  • Authority

    Australia TGA

    Accepted

    Yes

    Benefit

    Reference-country origin under Decreto 3275/2009

    Timeline Savings

    None published

  • Authority

    ANVISA (Brazil)

    Accepted

    No

    Benefit

    Brazil is not on the INVIMA reference-country list and there is no device mutual recognition agreement in force

    Timeline Savings

    None

Key Requirements
  • Colombia Registration Holder (CRH) - mandatory for foreign manufacturers
  • Spanish labeling and IFU
  • Free Sale Certificate
  • GMP certificate (ISO 13485)
  • Technical documentation
  • Post-registration: modifications to automatic registries are decided within 2 days; evaluation-type modifications carry a one-time information request with a 90-day window
Local Rep Required

Yes

Local Rep Name

Colombia Registration Holder (CRH)

Mdsap Accepted

No

Mdsap Benefit

Not officially recognized but ISO 13485 accepted

Registration Validity

10 years

Verification Status

official-verified

Official Sources
  • Title

    Decreto 4725 de 2005 — INVIMA statutory review clocks (Arts. 21-22)

    Url

    https://normograma.invima.gov.co/normograma/compilacion/docs/decreto_4725_2005.htm

    Accessed Date

    2026-08-25

  • Title

    INVIMA medical devices and biomedical equipment procedures — Formato Único numerals by risk class and the Decreto 3275/2009 homologation for reference countries

    Url

    https://www.invima.gov.co/productos-vigilados/dispositivos-medicos/dispositivos-medicos-equipos-biomedicos

    Accessed Date

    2026-08-30

Reviewed On

2026-08-30

Last Updated

2026-08-30

Process
Template Id

default

Status

planning-template

Usage Rule

Maintained planning steps and estimates, not verified regulator deadlines.

Steps
  • Step

    1

    Title

    Pre-Submission Preparation

    Description

    Gather technical documentation, quality management system (QMS) records, and clinical data required by INVIMA. Appoint a Colombia Registration Holder (CRH).

    Duration

    1-3 months

    Icon

    📋

  • Step

    2

    Title

    Application Submission

    Description

    Submit complete registration dossier to INVIMA including device description, risk analysis, and testing reports.

    Duration

    1-2 weeks

    Icon

    📤

  • Step

    3

    Title

    Administrative Review

    Description

    INVIMA reviews application for completeness. May request additional documents or clarifications.

    Duration

    2-4 weeks

    Icon

    🔍

  • Step

    4

    Title

    Technical Evaluation

    Description

    In-depth technical assessment of device safety and performance. INVIMA may issue questions.

    Duration

    2 working days

    Icon

    ⚙️

  • Step

    5

    Title

    Registration Approval

    Description

    Upon successful review, INVIMA issues Colombia market authorization certificate.

    Duration

    1-2 weeks

    Icon

    ✅

Government fee schedules · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Colombia fees →
Country

Colombia

Jurisdiction Id

colombia

Country Code

CO

Authority

INVIMA

Low Risk Local
Min

2570590

Max

3898330

Currency

COP

Per Product

Yes

High Risk Local
Min

3427372

Max

4412400

Currency

COP

Per Product

Yes

Details
  • Id

    md-application-class-i

    Item

    MD Application - Class I

    Currency

    COP

    Amount Local

    3898330

    Amount Local Formatted

    COP 3,898,330

    Frequency

    Per product

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.invima.gov.co/biblioteca/download/145278

    Source Title

    INVIMA 2026 tariff manual V3

    Source Effective Date

    2026-06-30

    Verified On

    2026-08-25

  • Id

    md-application-class-iia

    Item

    MD Application - Class IIa

    Currency

    COP

    Amount Local

    3898330

    Amount Local Formatted

    COP 3,898,330

    Frequency

    Per product

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.invima.gov.co/biblioteca/download/145278

    Source Title

    INVIMA 2026 tariff manual V3

    Source Effective Date

    2026-06-30

    Verified On

    2026-08-25

  • Id

    md-application-class-iib

    Item

    MD Application - Class IIb

    Currency

    COP

    Amount Local

    4412400

    Amount Local Formatted

    COP 4,412,400

    Frequency

    Per product

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.invima.gov.co/biblioteca/download/145278

    Source Title

    INVIMA 2026 tariff manual V3

    Source Effective Date

    2026-06-30

    Verified On

    2026-08-25

  • Id

    md-application-class-iii

    Item

    MD Application - Class III

    Currency

    COP

    Amount Local

    4412400

    Amount Local Formatted

    COP 4,412,400

    Frequency

    Per product

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.invima.gov.co/biblioteca/download/145278

    Source Title

    INVIMA 2026 tariff manual V3

    Source Effective Date

    2026-06-30

    Verified On

    2026-08-25

  • Id

    ivd-application-class-i-ii

    Item

    IVD Application - Class I/II

    Currency

    COP

    Amount Local

    2570590

    Amount Local Formatted

    COP 2,570,590

    Frequency

    Per product

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.invima.gov.co/biblioteca/download/145278

    Source Title

    INVIMA 2026 tariff manual V3

    Source Effective Date

    2026-06-30

    Verified On

    2026-08-25

  • Id

    ivd-application-class-iii

    Item

    IVD Application - Class III

    Currency

    COP

    Amount Local

    3427372

    Amount Local Formatted

    COP 3,427,372

    Frequency

    Per product

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.invima.gov.co/biblioteca/download/145278

    Source Title

    INVIMA 2026 tariff manual V3

    Source Effective Date

    2026-06-30

    Verified On

    2026-08-25

  • Id

    controlled-technology-commercialization-permit

    Item

    Commercialization or renewal permit - controlled-technology biomedical equipment (código 3005)

    Currency

    COP

    Amount Local

    4455511

    Amount Local Formatted

    COP 4,455,511

    Frequency

    Per permit

    Notes

    367.92 UVB at COP 12,110 per UVB (2026).

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.invima.gov.co/biblioteca/download/145278

    Source Title

    INVIMA 2026 tariff manual V3

    Source Effective Date

    2026-06-30

    Verified On

    2026-08-25

Notes
  • Amounts were checked in INVIMA's 2026 tariff workbook (base Resolución 2025067543 of 22 December 2025, modified by Resolución 2026033499 of 30 June 2026; UVB = COP 12,110 in 2026).
  • IVD registration (código 3040) is 212.27 UVB (COP 2,570,590) for the first product plus 84.87 UVB per additional product.
  • Microenterprises are exempt and other company sizes receive 40–90% differentiated tariffs under Ley 2069 de 2020 / Decreto 1889 de 2021.
  • A June 30, 2026 resolution modifies the current manual; always select the exact tariff code for the procedure.
Last Updated

2026-08-25

Verification Status

official-verified

Official Sources
  • Title

    INVIMA 2026 tariff manual V3

    Url

    https://www.invima.gov.co/biblioteca/download/145278

    Effective Date

    2026-06-30

    Accessed Date

    2026-08-25

Reviewed On

2026-08-25

Amount Status

exact-current

Range Available

Yes

Additional certifications and licences · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Colombia certifications →
Slug

colombia

Market

Colombia

Confidence

high

Schemes
  • Id

    invima-electrical-emc-evidence

    Name

    INVIMA electrical/EMC evidence

    Category

    Medical Electrical Safety

    Status

    Included In Medical Registration

    Object

    Finished Device

    Note

    No mandatory list of specific international test standards for general devices: Art. 4 Decreto 4725/2005 sets fundamental safety/performance requirements per intended purpose with risk control by inherent design safety, protective measures and residual-risk information; Art. 18(d) requires design verification/validation test reports or a certificate of analysis; equipos biomédicos must comply with specific technical standards/reglamentos técnicos in force; UDI-DI codes must come from an authorized issuing agency per Res. 1405/2022.

    Source Binding

    unresolved

  • Id

    crc-terminal-equipment-homologation

    Name

    CRC mobile-terminal homologation

    Category

    Telecom Network Attachment

    Status

    Mandatory If Feature

    Object

    Mobile Terminal Equipment

    Note

    Resolución CRC 6129 de 2020, compiled as Título VII of Resolución CRC 5050 de 2016. Art. 7.1.1.1 requires every terminal that meets the Title I definition of Equipo Terminal Móvil (ETM) to complete the homologation procedure; the CRC may later extend the duty to other terminals. Art. 7.1.1.2 lets the CRC homologate of its own motion or on application once it verifies the certificates in 7.1.1.2.1. Numeral 7.1.1.2.1 accepts a third-party certificate of conformity, declaration of conformity or equivalent from a nationally or internationally accredited body (Decreto 1074 de 2015 Art. 2.2.1.7.2.1), or a homologation certificate from a foreign competent authority, showing the technical standards adopted in Colombia. Recitals of 6129 record that importers and authorised public sellers must present the CRC homologation certificate to customs and must generate the corresponding certificate at the sale of each ETM. This is an ETM (mobile-network) overlay, not a short-range medical-radio type approval.

    Source Binding

    unresolved

  • Id

    decreto-4725-radiation-authorization

    Name

    Radiation-authority authorisation for controlled biomedical equipment

    Category

    Ionizing Radiation

    Status

    Mandatory If Feature

    Object

    Radiation Emitting Controlled Biomedical Equipment

    Note

    Decreto 4725 de 2005 Art. 23: equipos biomédicos de tecnología controlada that use radiation must hold an authorisation issued by the competent radiation authority for the handling of that equipment, in addition to the INVIMA commercialisation permit. Legal metrology was not opened in this pass.

    Source Urls
    • https://www.funcionpublica.gov.co/eva/gestornormativo/norma.php?i=18697
    Source Binding

    reviewed

  • Id

    res851-raee-electromedical-producer

    Name

    RAEE producer collection system for electromedical AEE

    Category

    Environmental And Batteries

    Status

    Mandatory If Feature

    Object

    Producer Introducing Electromedical Aee

    Note

    Resolución 851 of 5 August 2022 Art. 2 applies the RAEE rules to producers who place AEE on the national market; the only exclusion is strictly military weapons and munitions. Art. 4 Table 1 category 2 item 2.9 names equipos electromédicos, and Annex 1 lists electrodiagnostic, UV/IR medical, dental and implantable-aid tariff lines in that subcategory. Art. 5 requires every producer to establish, administer and finance a RAEE collection and management system, individually or collectively (Art. 6). Annex 1 also sets the import/manufacture unit threshold from which ANLA watches the system; merchandise in Annex 1 that is not AEE under Ley 1672 de 2013 may be excluded if the producer demonstrates that to ANLA (Art. 4 parágrafo 1).

    Source Urls
    • https://www.minambiente.gov.co/wp-content/uploads/2022/08/Resolucion-0851-de-2022.pdf
    Source Binding

    reviewed

Official Sources
  • Authority

    CRC (Compilación Jurídica)

    Topic

    Resolución CRC 6129 de 2020 compiled as Título VII of Resolución CRC 5050 de 2016, Arts. 7.1.1.1 and 7.1.1.2.1 ETM homologation

    Url

    https://normograma.crcom.gov.co/crc/compilacion/docs/resolucion_crc_6129_2020.htm

  • Authority

    Función Pública (Gestor Normativo)

    Topic

    Decreto 4725 de 2005 Art. 23 radiation authorisation for controlled biomedical equipment

    Url

    https://www.funcionpublica.gov.co/eva/gestornormativo/norma.php?i=18697

  • Authority

    Ministerio de Ambiente y Desarrollo Sostenible

    Topic

    Resolución 851 de 2022 Arts. 2, 4 Table 1 item 2.9 and 5 — RAEE producer system including electromedical AEE

    Url

    https://www.minambiente.gov.co/wp-content/uploads/2022/08/Resolucion-0851-de-2022.pdf

  • Authority

    CRC

    Topic

    terminal-equipment homologation technical requirements library

    Url

    https://www.crcom.gov.co/es/biblioteca-virtual/normas-tecnicas-y-requisitos-para-homologacion-equipos-terminales

Keep researching this market

More Colombia medical device resources

View the Colombia resource hub →
Compare regulatory data across all countries →
Continue with this market
DJ Fang
Need to apply Colombia's requirements to a product?
Confirm the current INVIMA pathway, evidence, and local-role details for the actual device before filing.
Pricing