🇨🇴 Colombia medical device regulatory data

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 advertising and non-compliance (contraviene/no contraviene) opinions; requests use form 'SOLICITUD DE AUTORIZACIÓN DE PUBLICIDAD' code ASS-RSA-FM096.

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 must not exaggerate benefits or mislead; Class IIa, IIb and III devices for exclusive professional use or requiring prescription may only be advertised in scientific or technical publications, unless the health authority authorizes other media; titulares and marketers are responsible for any breach.

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 grounds the titular may notify INVIMA/competent authority within one month of the deadline, and the authority may set a new term once, by reasoned resolution.

Type

Fixed Term

Description

10 years from issuance of the administrative act (Art. 31, Decreto 4725 de 2005)

If the registration or permit expires without a timely renewal request (or the request is abandoned/withdrawn or filed late), the product may not be imported into Colombia or manufactured; INVIMA gives interested parties up to 6 months to dispose of existing stock, after which it orders seizure (decomiso).

Renewal follows the same procedure as issuance for the technical and legal evaluations (quality-control analysis and BPM compliance verification may apply); the registration is renewed under the same number followed by 'R' plus a consecutive digit.

Years

10

Starts From

administrative-act-issuance

Months Before Expiry

3

Late Filing Consequence

processed as a new application

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 for controlled-technology biomedical equipment, and carries out sanitary surveillance.

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 Tecnologías is in charge of device oversight. Decreto 4725/2005 was issued under Ley 09/1979 Art. 564, Ley 100/1993 Art. 245 and Ley 715/2001 Art. 42.3.

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.

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 representation in Colombia must guarantee in-country technical support for the permit's validity.

• significant change affecting safety/effectiveness
• change in design
• change in chemical composition of material
• change in energy source
• change in manufacturing processes

An existing registration or marketing permit cannot be modified when a significant change may affect safety or effectiveness, including changes in design, chemical composition of materials, energy source or manufacturing processes; a new registration is required instead.

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 healthcare delivery; importing prototypes requires a technical opinion (concepto técnico) from INVIMA under the health-research rules in force.

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 analysis.

Serious adverse events occurring in clinical studies with medical devices must be notified to INVIMA using the official form 'FORMATO PARA NOTIFICACION AL INVIMA DE EVENTOS ADVERSOS SERIOS PRESENTADOS EN ESTUDIOS CLINICOS CON DISPOSITIVOS MEDICOS' (code ASS-RSA-FM171).

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.

The legal definition of medical device for human use expressly includes software ('cualquier instrumento, aparato, máquina, software, equipo biomédico u otro artículo similar'), provided the principal action is not pharmacological, immunological or metabolic.

IVD reagents are regulated separately by Decreto 3770 de 2004: category III (high risk) requires registro sanitario from INVIMA; categories I and II obtain automatic registro sanitario.

Equipo biomédico de tecnología controlada is a distinct category subject to permiso de comercialización: devices under special control for high risk, prototypes, offer-controlled technology, used or refurbished equipment, or equipment involving investment above 700 monthly minimum wages (SMMLV).

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 translation; if the document states no validity period, it is deemed valid for one year.

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 reference-country free-sale certificate; (c) proof of constitution, existence and legal representation of the titular, manufacturer and importer.

Article 18 lists the technical-evaluation dossier for devices that are not controlled technology: form endorsed by the technical director (name, presentation, manufacturer, shelf life, classification, indications, ECRI/GMDN code, warnings), copy of quality-system certification (CCAA or BPM or equivalent), device description, technical studies/test reports or certificate of analysis, sterilization and disposal methods, final label and insert artwork, free-sale certificate; for classes IIa/IIb/III scientific information and risk analysis, and for classes IIb/III clinical studies.

Archetype

Marketing Authorization Holder Or Registrant

Name

Titular of the registro sanitario / permiso de comercialización (natural or legal person)

Required For Foreign

yes - imported devices must identify on the label/packaging/IFU the importer in Colombia or the manufacturer's authorized representative

Registration Relation

Holds INVIMA Registration

Importer Relation

importer identified on labeling; change of importer processed as a modification

Distributor Relation

Can Be Separate

Combination

allowed

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

• solicitud via Formato Único ASS-RSA-FM007 (pestaña Modificaciones Automáticas)
• authorization of the titular to the new importer
• certificate of existence and legal representation of the new importer

Notes

Holder/importer changes are modification events, not new registrations; significant changes require a new registro (Art. 30 parágrafo).

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 Capacidad de Almacenamiento y Acondicionamiento (CCAA) and verifies compliance through periodic visits.

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 than 5 years from manufacture and in optimal operating condition, plus serial number and manufacture date; used class IIb/III equipment is prohibited. Refurbished (repotenciado) equipment of all classes may enter with a good-functioning certification from the legal manufacturer or its representative.

Microenterprises (including small producers per Decreto 691 de 2018) are exempt from payment of device registration fees under parágrafo 2 of Art. 2 of Ley 2069 de 2020; small and medium companies pay differentiated tariffs of 40-90% of the standard fee under Art. 2 parágrafo 1 of Ley 2069 de 2020 and Art. 5 of Decreto 1889 de 2021, by income bands.

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 imported devices the label, packaging or instructions for use must include the name and address of the importer in Colombia or the manufacturer's authorized representative.

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'.

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).

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 surveillance of medical devices for human use at every stage (production, import, export, processing, packaging, storage, sale).

Resolución 4816 de 2008 (Ministerio de la Protección Social) establishes the Programa Nacional de Tecnovigilancia, the mandatory adverse-event reporting system for medical devices in Colombia.

Resolución 1405 de 2022 (published Diario Oficial 52.120, 8 August 2022) adopts the semantic standard and UDI-DI coding for medical devices and IVDs.

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 consolidated periodic reports of all non-serious event reports to INVIMA; the institutional program must include a data-management system ensuring integrity/confidentiality and a Tecnovigilancia Manual analyzing reports by gravity, frequency and patient impact.

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 professional responsible for the program, communicate events to INVIMA, take immediate preventive/corrective actions, communicate international alerts associated with their devices, and cooperate promptly with INVIMA requests on device safety.

Device filings use the Formato Único de Diligenciamiento de Dispositivos Médicos, code ASS-RSA-FM007 (includes a 'Modificaciones Automáticas' tab for modification requests); advertising authorization uses form ASS-RSA-FM096 and non-commercialization notification uses ASS-RSA-FM107.

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 web aplicativo at farmacoweb.invima.gov.co/TecnoVigilancia.

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 BPM implementation is pending, INVIMA issues a technical opinion on sanitary conditions, and per INVIMA's current FAQ national manufacturers need only the 'certificación de condiciones sanitarias'.

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 tools needed to keep equipment within the safety ranges set by the manufacturer; responsibility for functioning is shared between the manufacturer (or its representative in Colombia for imports) and the owner/holder.

The registration dossier accepts a copy of the certification of the quality system used - CCAA or BPM or its equivalent - so foreign quality-system certificates are accepted as equivalent; INVIMA may verify quality conditions when it considers pertinent.

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.

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 titular or distributor must inform INVIMA when executing preventive measures or market alerts and when disseminating warnings related to devices (Decreto 4725 Art. 62).

• I
• IIa

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 with a 90-business-day statutory term from completeness; controlled-technology biomedical equipment requires permiso de comercialización.

Equipos biomédicos de tecnología controlada require a permiso de comercialización from INVIMA (instead of registro sanitario); equipment using radiation additionally needs an authorization from the competent radiation authority.

Medical devices and biomedical equipment that are not controlled technology of risk classes IIb and III require a registro sanitario issued by INVIMA before production, import, export, processing, packaging, storage, sale or marketing.

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 the corresponding registration/permit, and demonstrations may never involve use in patients when the product is not approved in the country of origin or reference countries.

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 country, proof of the petitioner's existence and representation, and a product quality certificate, in three cases: (a) calamity or emergency determined by the Health Ministry; (b) devices/controlled equipment with authorized clinical investigation in Colombia; (c) vital unavailable devices (unless in clinical investigation or with market substitutes), for which the patient's full name and clinical-history summary are required.

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 (before the immediate administrative or functional superior); both must be filed in writing at personal notification or within 10 days of it; the apelación is required before going to court and may be filed as subsidiary to reposición.

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 (desistimiento) with no refund of the fee.

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, serial and/or lot number, acquisition date, shipping/supply date, and identification of the first customer.

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 class IIb, 24 months for classes IIa and I (same months for IVD categories III/II/I); registrations obtained after the implementation period must report the UDI-DI before commercialization with no transition.

UDI-DI/semantic-standard reporting is done by titulares of valid registrations on the platform estandar.invima.gov.co before commercialization, reporting basic (UDI-DI, GMDN code and term, registro sanitario, issuing agency), regulatory and commercial attributes; after paying tariff 4003-1 INVIMA issues an electronic oficio. UDI-DI on the physical label is not required.

To market devices in Colombia, the titular of the registro sanitario or permiso de comercialización must obtain the UDI-DI code and complete the reporting procedure (Capítulo III of Resolución 1405 de 2022); the code uniquely identifies human-use medical devices and IVDs and is issued by authorized agencies (GS1, HIBCC, ICCBBA, IFA, ALI HEALTH, ZIIOT).

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 quarterly non-serious mass reports use the RETEIM format; report forms must contain the minimum fields of Resolución 4816 de 2008.

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 4816 de 2008.

Manufacturers and importers of devices, health-service providers, independent professionals, users and any person with knowledge of an adverse event or incident must report it to the corresponding instance of the Programa Nacional de Tecnovigilancia; separately, the registration/permit titular, manufacturer or representative and users must notify INVIMA of all adverse incidents and incorrect or improper use.