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INVIMA · Americas

Colombia medical device regulatory resources

Every Colombia dataset, comparison, and AI workpaper we maintain — one entry point for the whole market.

390,583 registration records11 free resources24/25 topics with records15 regulations trackedAug 2026 fees reviewed
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Everything we track for Colombia

Medical device registration database

Search official INVIMA device registration records.

Medical device registry insights

Explore market trends, registrations, manufacturers, and local representatives.

Medical device regulations

Browse official INVIMA regulations and guidance documents.

Registration timeline

Compare official and realistic approval times by device class and pathway.

Government registration fees

Review current INVIMA application, review, and renewal fees.

AI registration cost and timeline planner

Estimate the likely INVIMA pathway, government fees, dossier preparation time, review timeline, and registration steps.

Medical device regulation news

Follow recent INVIMA policy, guidance, and compliance updates.

AI medical device classifier

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Additional certification and licence checker

Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other Colombia requirements.

AI similar registered product finder

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Regulatory requirements data

Browse source-linked lifecycle, language, local-role, renewal, and change-control facts.

Structured regulatory requirements

Explore all 62 source-linked facts →

24 of 25 research dimensions currently covered · 18 official sources · latest verification 2026-09-15

Market entry

D01

Authority & regime

Verified
Competent authority
INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos) is the national authority that issues the registro sanitario for medical devices and the permiso de comercialización fo…
Ministry relationship
INVIMA acts as the national sanitary reference institution and executes the policies of the Ministerio de Salud y Protección Social; its Dirección de Dispositivos Médicos y Otras Tecnología…
2 source-linked facts
Checked 2026-08-25
Open details →
D02

Legal basis & guidance

Verified
Amending decrees
Decreto 4725 de 2005 is amended by Decreto 3275 de 2009 (scope, Art. 1) and Decreto 582 de 2017 (application procedure Art. 21 and automatic modification regime Art. 30).
Base regulation
Decreto 4725 de 2005 (signed 26 December 2005, in force from its publication, repealing Decreto 2092 de 1986) governs registros sanitarios, permiso de comercialización and sanitary surveill…
4 source-linked facts
Checked 2026-08-25
Open details →
D03

Device definition & scope

Verified
General medical-device scope
Decreto 4725 de 2005 regulates medical devices for human use at all stages and excludes IVD reagents and custom made devices (dispositivos médicos sobre medida) from its scope.
Definition includes software
The legal definition of medical device for human use expressly includes software ('cualquier instrumento, aparato, máquina, software, equipo biomédico u otro artículo similar'), provided th…
4 source-linked facts
Checked 2026-08-25
Open details →
D04

Classification rules

Verified
Risk classes I, IIa, IIb and III (Decreto 4725 de 2005) plus IVD categories I-III (Decreto 3770 de 2004).
Class I, Class II, Class IIa, Class IIb, Class III
1 maintained scheme
Checked 2026-08-25
Open details →
D05

Registration pathways

Verified
Automatic registration classes
I; IIa
Market-access route by class
Classes I and IIa obtain an automatic registro sanitario issued within 2 days of complete documentation; classes IIb and III obtain a registro sanitario after technical/legal evaluation wit…
4 source-linked facts
Checked 2026-08-25
Open details →
D06

Reliance & recognition

Verified
China NMPA approval: not reference
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…
China NMPA approval: origin evidence only
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 produ…
3 source-linked facts
Checked 2026-09-15
Open details →
D07

Economic-operator roles

Verified
Local market-entry role
archetype: marketing authorization holder or registrant · name: Titular of the registro sanitario / permiso de comercialización (natural or legal person) · required for foreign: yes importe…
Representative or importer change
path code: modification of registration (automatic under Art. 30 D. 582/2017; 'modificaciones de carácter legal') · fresh registration: usually no for valid registration · minimum handover:…
2 source-linked facts
Checked 2026-08-25
Open details →
D08

Establishment, import & distribution

Verified
Importer storage-capacity certificate
All importing and marketing establishments for medical devices must meet storage and conditioning capacity requirements (set by the Health Ministry); INVIMA issues the Certificado de Capaci…
Used and refurbished equipment import
Used biomedical equipment may be imported/acquired/donated only in classes I or IIa (treated as tecnología controlada), with a manufacturer/importer certificate that equipment is not more t…
2 source-linked facts
Checked 2026-08-25
Open details →
D09

Dossier requirements

Verified
Foreign document formalities
Official documents issued abroad must be authenticated by the Colombian consul and the Ministry of Foreign Affairs or bear an apostille; documents not in Spanish require official translatio…
Import dossier additions
For imported devices, the dossier additionally requires: (a) commercial history referencing countries where the device is sold and related alerts; (b) country of origin authorization or ref…
3 source-linked facts
Checked 2026-08-25
Open details →
D10

Official forms & portals

Verified
Unified device form
Device filings use the Formato Único de Diligenciamiento de Dispositivos Médicos, code ASS RSA FM007 (includes a 'Modificaciones Automáticas' tab for modification requests); advertising aut…
Transaction portals
INVIMA filings run through the Oficina Virtual (app.invima.gov.co/ovirtual); UDI DI/semantic standard reporting uses estandar.invima.gov.co; adverse event reporting uses the tecnovigilancia…
2 source-linked facts
Checked 2026-08-25
Open details →

Submission & evidence

D11

Label, IFU & language

Verified
IFU and importer identification
Labeling must give information needed to identify and safely use the device, supplied on the device itself and/or packaging or accompanying material, in easily comprehensible terms; for imp…
Spanish label elements
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 a…
2 source-linked facts
Checked 2026-08-25
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D12

QMS, audit & inspection

Verified
BPM for manufacturers (transitional)
Establishments that manufacture, semi process, package or pack medical devices must comply with the device Good Manufacturing Practices (BPM) issued by the Health Ministry (Art. 8); while B…
Post-sale maintenance duty
For dispositivos médicos considered equipos biomédicos, in post sale the manufacturer or importer must offer verification, maintenance and calibration services with the spare parts and tool…
3 source-linked facts
Checked 2026-08-25
Open details →
D13

Standards, testing & ancillary approvals

Unresolved
INVIMA electrical/EMC evidence
Electrical safety
CRC mobile-terminal homologation
Telecom terminal
Radiation-authority authorisation for controlled biomedical equipment
Radiation
4 maintained overlays
Open details →
D15

Review clocks

Verified
Class I · Notification (NSO)
2 working days
Class IIa · Registration (NSO)
2 working days
Class IIb · Registration (RSO)
90 working days
4 maintained pathways
Checked 2026-08-30
Open details →
D16

Approval validity & renewal

Verified
First-commercialization deadline
Holders must commercialize the product within 36 months from the administrative act (or code) granting the registro or permiso; failure results in automatic cancellation. On justified groun…
Authorization duration
type: fixed term · description: 10 years from issuance of the administrative act (Art. 31, Decreto 4725 de 2005)
6 source-linked facts
Checked 2026-08-26
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Lifecycle & post-market

D17

Change control

Verified
Automatic modification procedure
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 appro…
Voluntary market-exit notice
Titulares of registros or permisos wishing to withdraw their products from the market must inform INVIMA in advance; permiso holders of controlled technology equipment without representatio…
4 source-linked facts
Checked 2026-08-25
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D18

UDI, listing & traceability

Verified
Distribution traceability records
Establishments that import or market devices must keep documentation of products distributed or destined for use in Colombia for traceability, containing at minimum: trade name, model, seri…
UDI phased compliance
After an 18 month implementation period from publication, holders of existing registrations had phased deadlines counted from the end of that period: 12 months for class III, 18 months for…
4 source-linked facts
Checked 2026-08-25
Open details →
D19

Clinical investigation & performance

Verified
Prototype devices for research only
Prototype medical devices and controlled technology biomedical equipment (national or imported) may be authorized only for research and experimentation purposes and may never be used in hea…
Clinical studies in Class IIb/III dossier
For classes IIb and III, the technical evaluation dossier must include clinical studies (estudios clínicos); for classes IIa, IIb and III it must include scientific information and risk ana…
3 source-linked facts
Checked 2026-08-25
Open details →
D20

Special access & derogation

Verified
Fairs and demonstrations
Products not complying with the decree may be shown at fairs, expositions and demonstrations if previously authorized for that purpose; they cannot be marketed or put into service without t…
Import without registration (Art. 48)
INVIMA may exceptionally authorize import of finished devices without a registro sanitario or permiso de comercialización, on request accompanied by a free sale certificate from the origin…
2 source-linked facts
Checked 2026-08-25
Open details →
D21

Manufacturer PMS

Verified
Periodic safety reporting
Responsible professionals must register, analyze and manage every adverse event or incident possibly caused by a device, inform INVIMA immediately of serious events, and send quarterly cons…
Manufacturer/importer tecnovigilancia duties
Manufacturers and importers must design and implement an institutional Tecnovigilancia Program ensuring permanent follow up of adverse events and incidents, designate at least one competent…
2 source-linked facts
Checked 2026-08-25
Open details →
D22

Vigilance & incident reporting

Verified
Reporting channel and formats
Reports are filed through INVIMA's tecnovigilancia web aplicativo (farmacoweb.invima.gov.co/TecnoVigilancia), requiring role based registration; serious events use the FOREIA module and qua…
Serious-event deadline
Serious adverse events and incidents (EVENTOS/INCIDENTES ADVERSOS SERIOS) must be reported to INVIMA within 72 hours of occurrence, with the report content set by Article 14 of Resolución 4…
3 source-linked facts
Checked 2026-08-25
Open details →
D23

Recall, FSCA & market surveillance

Verified
International alert notification
Importers must notify INVIMA of international alerts associated with devices they import within 72 hours of learning of the alert, together with the actions taken.
Withdrawal and recall notification
Manufacturers and importers must notify INVIMA of total or partial market withdrawals when products pose a risk to patients' health (Res. 4816 Art. 19); the manufacturer, registration titul…
2 source-linked facts
Checked 2026-08-25
Open details →
D24

Advertising, claims & promotion

Verified
INVIMA advertising authorization
INVIMA issues the authorization to advertise medical devices or biomedical equipment in Colombia under Article 58 of Decreto 4725 de 2005, issuing resolutions approving or denying advertisi…
Advertising content restrictions
Scientific, promotional or advertising information must follow the conditions of the registration/permit and current technical legal rules, stick to the truth with scientific evidence, and…
2 source-linked facts
Checked 2026-08-25
Open details →
D25

Submission communications & appeal

Verified
Administrative appeals
Against definitive INVIMA administrative acts, the general administrative remedies are recurso de reposición (filed before the authority that issued the decision) and recurso de apelación (…
Deficiency response rule
During registration evaluation INVIMA may request additional information only once; the applicant must supply it within 90 days, failing which the petition is deemed withdrawn (desistimient…
2 source-linked facts
Checked 2026-08-25
Open details →

Government fees

Full fee schedule (7 lines) →

INVIMA registration fees in COP · reviewed 2026-08-25

Fee lineAmountProvenance
MD Application - Class ICOP 3,898,330Verified
MD Application - Class IIaCOP 3,898,330Verified
MD Application - Class IIbCOP 4,412,400Verified
MD Application - Class IIICOP 4,412,400Verified
3 more fee lines on the full schedule · 7 of 7 rows source-verified

Registration timeline

Full registration timeline →

Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA) review clocks and planning ranges · 4-class (I, IIa, IIb, III) classification

Class / pathwayReview clockPlanning totalProvenance
Class I(Notification (NSO))2 working days1-2 monthsVerified
Class IIa(Registration (NSO))2 working days1-2 monthsVerified
Class IIb(Registration (RSO))90 working days6-12 monthsVerified
Class III(Full Registration (RSO))90 working days9-18 monthsVerified
  1. 1Pre-Submission Preparation(1-3 months)
  2. 2Application Submission(1-2 weeks)
  3. 3Administrative Review(2-4 weeks)
  4. 4Technical Evaluation(2 working days)
  5. 5Registration Approval(1-2 weeks)

Latest regulation news

All Colombia regulation news →

Newest official INVIMA headlines from the daily-refreshed feed — every row links directly to the authority publication.

Sep 11ININVIMAMedical Device Safety Alert: StatStrip LAC Test StripsColombiaAug 31ININVIMAINVIMA Issues Safety Report for Philips IntelliVue and SureSigns Multiparameter MonitorsColombiaAug 31ININVIMAINVIMA Issues Safety Report for SEMA Diagnostic SoftwareColombiaAug 31ININVIMAINVIMA Issues Safety Report for HemoSphere Advanced Monitoring Platform and AccessoriesColombiaAug 31ININVIMAINVIMA Safety Report: Clinical Information Central Station, Accessories, and Spare PartsColombia

Key regulations

All 15 Colombia regulations →

Official INVIMA rules and guidance · 15 of 15 documents linked to official sources

Decreto 1030/2007Technical Requirements for Custom Medical Devices
GMP/QMSVerified
Decreto 1036/2018Orphan, Research and Laboratory IVD Reagents
RegistrationVerified
Decreto 3275/2009Modification to Medical Device Registration Requirements
RegistrationVerified
Decreto 334/2022Health Registration Renewal and Advertising Requirements
RegistrationVerified

Registry insights

Full registry statistics →

Computed from 390,583 official INVIMA registration records · data as of 2026-08-20

266,115
Active registrations
9,452
Manufacturers
4,038
Registration Holders
70
Origin countries
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Colombia market-launch workpaper

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Colombia dossier reuse and delta

Compare an existing authorization and evidence set against INVIMA administrative, testing, labeling, and dossier needs.

Colombia change notification workpaper

Map a product or manufacturing change to INVIMA evidence, notification, timing, and implementation questions.

Colombia regulatory change impact

Assess a current INVIMA update against one product and turn it into an owner-ready action workpaper.

Colombia cybersecurity evidence review

Review connected-device architecture, risks, SBOM, testing, lifecycle controls, and market-specific questions for Colombia (INVIMA).

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