How do you register a medical device with INVIMA in Colombia?

Registration routes, dossier documents, timelines, fees, titular rules, and tecnovigilancia for medical devices entering the Colombian market — answered in one place.

October 1, 2026

13

min read

By

BioAccess Editorial Team

Colombia

INVIMA

medical device registration

market access

Latin America

registro sanitario INVIMA

Decreto 4725

**Key takeaways**

• • Yes — registration is mandatory. INVIMA requires a registro sanitario before any medical device is produced, imported, or commercialized in Colombia (Decreto 4725 de 2005).
• • Two routes by risk class. Class I/IIa devices get a registro sanitario automático (issued within 2 days of document evaluation); Class IIb/III devices require a full prior evaluation (90 business days statutory).
• • The importer must be Colombian. The importer of record must be an established Colombian entity holding INVIMA's CCAA; the filing runs through a Colombian apoderado.
• • 10-year validity with a renewal filing due 3 months before expiry — a late renewal is treated as a new application.
• • No formal FDA/CE fast track, but a reference-country Certificate of Free Sale substitutes several technical dossier items for Class I–IIb devices.

**Who is this for?**

This guide is for regulatory affairs directors, market access managers, and MedTech executives planning to commercialize medical devices — interventional cardiology, orthopedics, diagnostics, and related products — in Colombia.

The short answer

Yes. Every medical device or biomedical equipment that is not controlled technology requires a registro sanitario from INVIMA — the Instituto Nacional de Vigilancia de Medicamentos y Alimentos — before production, import, export, processing, packaging, storage, dispensing, or commercialization in Colombia (Decreto 4725 de 2005, Articles 16–17). Colombia runs two distinct routes: a registro sanitario automático for Class I and IIa devices, and a registro sanitario with prior evaluation for Class IIb and III devices. The filing is prosecuted through a Colombian apoderado (attorney), the importer of record must be an established Colombian entity holding INVIMA's CCAA certification, and import licenses move through the VUCE single window — shipping first and registering later is not a workable strategy. For manufacturers who want a turnkey path, see bioaccess®'s market access services.

What is INVIMA and what law requires registration?

INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos) is Colombia's national health-products authority, created under Ley 100 de 1993, operating within the Ministry of Health and Social Protection. For medical devices, its authority comes from Decreto 4725 de 2005 — "por el cual se reglamenta el régimen de registros sanitarios, permiso de comercialización y vigilancia sanitaria de los dispositivos médicos para uso humano" — which remains the governing framework as of this writing, as amended by:

• Decreto 3275 de 2009 — added the reference-country CVL substitution rule (Article 18, paragraph 3)
• Decreto 1313 de 2010 — derogated one documentary item of Article 18
• Decreto 582 de 2017 — set the 90-business-day term for Class IIb/III evaluations and made post-approval modifications automatic

Supporting rules include Resolución 4002 de 2007 (the CCAA manual for storage and conditioning capacity), Resolución 4816 de 2008 (the national tecnovigilancia program), and Ley 962 de 2005, Article 57 (posterior control of automatic registrations). A draft replacement decree — WTO/TBT-notified in May 2026 — would modernize the regime and introduce, among other things, a Colombian-domicile requirement for the titular and a formal reliance route for devices authorized by reference regulators. It is not in force; confirm its status at the proposal stage.

The two routes: automatic vs. evaluated registration

Colombia's most distinctive feature is that low-risk devices do not wait in an evaluation queue. The split, confirmed in INVIMA's official cartilla (ABC of medical devices, citing Articles 16–17 of Decreto 4725 and Decreto 582 de 2017):

Both registrations carry the "DM" prefix in the registro number and record the registro modality (e.g., importar y vender), the names and domiciles of the titular, fabricante, and importador, the risk classification, and the authorized commercial presentations (Article 20). Controlled-technology biomedical equipment follows a separate permiso de comercialización route (Article 23).

How are medical devices classified in Colombia?

Colombia uses four risk classes (Article 5 of Decreto 4725), with the classification made by the manufacturer following the classification rules of Article 7 — based on duration of body contact, degree of invasiveness, and local versus systemic effect:

Classification determines the route, the dossier depth, and whether clinical evidence is required: Class IIb and III devices must submit clinical studies (Article 18(k)), while Class I, IIa, and IIb can benefit from the reference-country CVL substitution rule (Article 18, paragraph 3).

Can a foreign manufacturer hold the registro directly?

There is no express rule in Decreto 4725 requiring the titular itself to be domiciled in Colombia. The decree records the titular (holder), the fabricante (manufacturer), and the importador (importer) as separate roles on the registro (Article 20), and INVIMA practice has long accepted foreign manufacturers as titular. In practice, however, a foreign manufacturer cannot act alone:

• The importer of record must be an established Colombian entity holding INVIMA's CCAA (Certificado de Capacidad de Almacenamiento y Acondicionamiento) — required for any importer of devices (Articles 16–17; Resolución 4002 de 2007)
• The filing and all notifications run through a Colombian apoderado (attorney) under power of attorney, with the applicant's legal existence proven by apostilled corporate documents
• The manufacturer must issue a written authorization designating who is empowered to import, commercialize, and/or be the titular (Article 29(d))

Note the forward-looking wrinkle: the draft replacement decree would make Colombian domicile of the titular an express requirement for the first time. A foreign manufacturer choosing to hold the registro in its own name today should plan for a transition if the draft is adopted as written.

**Titular choice is a commercial decision, not just a regulatory one**

Our recommendation for Colombia: appoint your Colombian distributor as both the titular (holder) and the importer of record, engage a third-party regulatory provider like bioaccess® to prepare and prosecute the INVIMA filing, and build registration-transfer (cesión) clauses into your distribution agreement — reviewed by Colombian counsel to ensure they are locally enforceable — so the registro can be transferred to a replacement distributor if the first one fails to meet expectations. A change of titular or importer is processed as a modification of the existing registro under the automatic-modification rule (Article 30, Decreto 582 de 2017) — but it requires the cooperation of the outgoing titular, which is exactly why ownership should be negotiated up front. (Argentina is the exception: it is a large enough market that bioaccess® provides full titleholder and importation services there directly.)

What documents does the INVIMA dossier require?

The technical and legal documentation is set out in Articles 18, 19, and 29 of Decreto 4725. For an imported Class IIa/IIb interventional device, the expediente typically contains:

Technical documentation (Article 18)

• Completed INVIMA form, endorsed by the technical director: generic name or brand, commercial presentation, manufacturer, registro modality, useful life, risk classification, indications and uses, international code (ECRI/GMDN), warnings, precautions, and contraindications
• Quality-system certification — CCAA/BPM or its equivalent; INVIMA accepts ISO 13485 for foreign manufacturers
• Device description: main parts, composition, specifications, functioning, descriptive information
• Technical studies and analytical verifications: design verification and validation summaries or finished-product certificates of analysis with acceptance specifications
• Sterilization method (when applicable); disposal or final-disposition method (when applicable)
• Final artwork for labels and inserts — labeling and IFU in Spanish per the decree's etiquetado provisions (Articles 53–55)
• For classes IIa/IIb/III: the scientific information supporting product safety plus a risk analysis per the device's indications
• For classes IIb/III: clinical studies demonstrating safety and effectiveness
• Certificate of Free Sale (CVL) — per Article 29(b), from the competent authority of the country of origin, or from a reference country (European Economic Community, United States, Canada, Japan, Australia) or a mutual-recognition country when the device is not marketed in the origin country

Legal documentation (Articles 19 and 29)

• Name or corporate name of the applicant; proof of legal existence and representation of the fabricante and/or titular
• Power of attorney for the Colombian apoderado prosecuting the filing
• Proof of payment of the government tariff
• For imported devices: the manufacturer's commercial history for the device and any alerts involving it (Article 29(a))
• The manufacturer's written authorization designating who may import, commercialize, and/or be the titular (Article 29(d))
• The importer's CCAA certificate and Colombian corporate registration

**The reference-country CVL is the dossier's highest-value document**

For Class I, IIa, and IIb devices, a Certificate of Free Sale issued within the last year by a reference-country authority (EU member-state authority, FDA, Health Canada, MHLW, TGA) can replace the design verification summaries, sterilization method, disposal method, and clinical-information items of Article 18 (paragraph 3, added by Decreto 3275 de 2009). Class III devices get no such substitution — the full technical file is reviewed. Foreign legal documents (powers of attorney, certificates of existence, notarized QMS certificates) must be apostilled or legalized and officially translated.

How long does INVIMA registration take?

Two practical warnings. First, the deficiency clock is fatal: for evaluated registrations, a single information request gives you 90 days to respond — miss it and the application is deemed withdrawn with no refund of the tariff (Article 21(c)). For automatic registrations, a failed posterior verification suspends the registro, and three months of suspension without correction means cancellation (Article 22, paragraph). Second, samples may be requested by INVIMA at any time, but their presentation is not a filing requirement (Article 21, paragraph 1). bioaccess® confirms the expected timeline at the proposal stage based on the device's class and dossier readiness.

What does INVIMA registration cost?

INVIMA government fees are set by the current manual tarifario, which carries separate tariff codes for automatic (Class I/IIa) versus evaluated (Class IIb/III) device registrations and denominates them in UVT/SMLDV units — the automatic route costs meaningfully less than the evaluated route. Because INVIMA adjusts the tarifario by resolution (most recently Resolución 2026058314 of September 2026, focused on medicines, foods, cosmetics, and BPM certifications), confirm the current manual tarifario at the proposal stage rather than budgeting from published tables. Microenterprises and small producers can qualify for fee exemptions under the applicable regulations.

The commercial budget drivers are the dossier, the reference-country CVL, apostille and official translations, and the local regulatory work — not the government tariff. The registro sanitario is valid for 10 years from issuance (Article 31). Renewal is an affirmative filing obligation: file 3 months before expiry; if the scientific information on file is unchanged and current, a declaration to that effect replaces re-filing it (Article 32, paragraph 2). If the registro expires without a timely renewal request, the device may no longer be imported or manufactured, INVIMA grants at most 6 months to exhaust existing stock, and any remaining product is subject to seizure (Article 32, paragraph 1).

Is there a fast track for FDA-cleared or CE-marked devices?

INVIMA does not operate a formal fast-track or reliance program for FDA-cleared or CE-marked devices — there is no equivalent of the abbreviated routes some other Latin American regulators run. What Colombia offers instead are document-substitution rules that materially lighten the filing for a 510(k) or CE device:

• The FDA Certificate to Foreign Government (CFG), or a free-sale certificate from an EU member-state competent authority, satisfies the Article 29(b) CVL requirement
• For Class I/IIa/IIb devices, that CVL replaces the design verification summaries, sterilization method, disposal method, and clinical-information items (Article 18, paragraph 3)
• The automatic route for Class I/IIa devices is itself the fastest lane — available regardless of FDA/CE status, and especially light when combined with the CVL substitution
• The manufacturer's QMS certificate is accepted 'or its equivalent' (Article 18(b)) — INVIMA accepts ISO 13485 and, in practice, CE full-quality-assurance certificates

Class III is the boundary: no CVL substitution applies, and the full technical file — including clinical evidence — is reviewed; your 510(k) or CE technical documentation is persuasive but not binding on INVIMA. Forward-looking: the draft replacement decree would create a formal optimized-analysis procedure based on recognized foreign regulators (FDA 510(k)/PMA/De Novo, Health Canada licence, TGA/ARTG), with simple translations and no apostille where the document is verifiable online. It is not in force — but sponsors sequencing a 510(k)/CE device for Colombia should know it is coming.

What are the tecnovigilancia obligations?

Colombia runs a national post-market surveillance program for devices — Tecnovigilancia, regulated by Resolución 4816 de 2008 (complementing Decreto 4725). The obligations fall on manufacturers, importers, health-care providers, and health secretariats:

• Serious adverse events and incidents must be reported to INVIMA within 72 hours of becoming known (Article 15), via the FOREIA format in the Tecnovigilancia web application
• Non-serious events are reported as quarterly consolidated filings by manufacturers and importers (Article 16)
• The Colombian importer is the local vigilance node — it receives provider reports, manages corrective actions, and files with INVIMA
• Importers and providers should routinely consult INVIMA's safety alerts, recalls, and theft notices (RISARH)

As your registration processor, bioaccess® runs the tecnovigilancia program for the filing — vigilance reporting, alert monitoring, and coordination with the titular/importer — so this does not become an unfunded afterthought.

What happens if you import without registration?

Colombia's enforcement runs through the import process itself. Import licenses for products under INVIMA's competence are processed through VUCE (Ventanilla Única de Comercio Exterior), and the INVIMA concept tied to a valid registro sanitario is the prior-control measure — customs (DIAN) correlates the licensed importer with the manufacturer declared in the registro before release. Without a registration, commercial import is not available:

• No registro sanitario, no commercial import — only narrow non-commercial routes exist (devices for authorized clinical investigations, vitales no disponibles, donations to health-care institutions)
• An expired registro without a timely renewal request blocks import and manufacture outright; INVIMA grants at most 6 months to exhaust existing stock, then orders seizure (Article 32, paragraph 1)
• Distributors, hospitals, and public tendering bodies require the registro sanitario number before purchase — registration is a commercial prerequisite, not just a customs formality
• Devices imported for a clinical investigation enter under a study-specific INVIMA authorization, not under a commercial registro — see our guide to the <Link to="/blog/invima-clinical-trial-approval-process-colombia" className="text-primary hover:underline font-semibold">INVIMA clinical trial approval process in Colombia</Link>

**No 'ship first, register later' strategy**

The registro number must be in place before the VUCE import license is filed. Budget registration into your launch timeline from day one — the automatic route for Class I/IIa devices is fast, but dossier preparation (CVL, apostille, translations, importer CCAA) is the real critical path.

Frequently Asked Questions

Sources and basis of this article

This article is based on the Colombian regulatory framework as of October 2026: Decreto 4725 de 2005 (as amended by Decretos 3275 de 2009, 1313 de 2010, and 582 de 2017) — consolidated text at INVIMA's normograma; INVIMA's official ABC cartilla on device registration types (Articles 16–17, Decreto 582 de 2017) at invima.gov.co; INVIMA's devices and biomedical equipment page, including the CCAA requirements and FAQs, at invima.gov.co; Resolución 4816 de 2008 (Programa Nacional de Tecnovigilancia) at invima.gov.co; INVIMA's 2026 tariff adjustment (Resolución 2026058314) as covered by ConsultorSalud; and regulatory analysis with Mike Legal AI (decision support, not a licensed attorney). Fees, timelines, and resolution-level details change by INVIMA notice — confirm the current manual tarifario and requirements with the Colombian titular or INVIMA directly before budgeting. This article is general information, not legal advice.

BA

bioaccess® · End-to-end medical device registration and market access services — an Americas company operating from Canada to Argentina, including INVIMA (Colombia), COFEPRIS (Mexico), ANVISA (Brazil), and ANMAT (Argentina).

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INVIMA Clinical Trials

Ready to register your device with INVIMA?

Colombia is one of Latin America's largest device markets — and entry runs through INVIMA registration: the right route by risk class, a Colombian importer with CCAA, an apostilled CVL-based dossier, and a tecnovigilancia program that lives after approval. bioaccess® prepares and prosecutes your INVIMA filing as your third-party regulatory provider — dossier, translations, agency liaison, and tecnovigilancia — while your Colombian distributor holds the registro as titular and importer of record, with transfer clauses in your distribution agreement protecting you if the commercial relationship changes.

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Related resources:

• Market Access Services — /market-access
• INVIMA clinical trial approval process in Colombia — /blog/invima-clinical-trial-approval-process-colombia
• U.S. medical device LATAM market-entry strategy — /blog/us-medical-device-latam-market-entry-strategy-sequence