INVIMA clinical-trial submission checklist for medical device studies in Colombia

Sponsors keep asking “what are INVIMA requirements for clinical trial submission” as if Colombia had one petition that covers ethics, investigation authorization, import, and later Registro Sanitario. It does not. The device clinical-research file is a stack of instruments and published forms. Confusing any one of them with a sanitary-registration dossier is how first patient slips a cycle.

I am Julio Martinez-Clark, CEO of bioaccess®. This checklist is for medical-device clinical research filings under INVIMA. It is grounded in the live Colombia clinical-trial execution pillar and is distinct from our INVIMA Registro for already FDA-cleared or CE-marked devices market-auth page and from the older FIH Colombia playbook. It is not a quote and not legal advice.

Separate four desks before you open a folder

Write four owners on one page before you assemble Spanish translations:

1. Ethics (CEI). An INVIMA-approved research ethics committee at an IPS that holds a current BPC certificate.
2. INVIMA investigation opinion. For devices, the Sala Especializada de Dispositivos Médicos y Reactivos de Diagnóstico In Vitro (SEDMRDIV), supported since 20 September 2022 by the GICASE group created under Resolución 2022035262.
3. Import of the investigational article. Exceptional importation without sanitary registration where the device is the subject of clinical research authorized in Colombia — Decreto 4725 de 2005 Article 48(b), against a prior specialized-chamber opinion.
4. Registro Sanitario (later, optional). Marketing authorization under the same decree’s Articles 18–19. Class IIb and III devices later need clinical evidence under Article 18(k). That is a commercial file, not the trial submission.

If your Gantt has one bar labeled “INVIMA,” you do not have a submission plan. You have a hope.

The governing instruments for device clinical research

Colombia has no single device clinical-trial regulation. Three working instruments carry most of the obligation:

• Decreto 4725 de 2005 — sanitary regime for human-use medical devices. Article 2 defines a device intended for clinical investigation. Article 36 authorizes a national or imported prototype (or controlled-technology biomedical equipment) for research and experimentation only, not for health care, against an INVIMA technical opinion. Article 48(b) is the import hook. Article 18(k) closes the commercial loop for class IIb and III Registro Sanitario.
• Resolución 8430 de 1993 — scientific, technical and administrative rules for health research with human beings. INVIMA names it as the governing human-subjects instrument.
• Resolución 2378 de 2008 — Good Clinical Practices with mandatory application for institutions researching medicines in humans, and the basis of the site BPC certificate that device trials also need in practice.

INVIMA remains one of eight PAHO Level IV Regional Reference Regulatory Authorities. Since 2022 it has published device-study approval and non-approval registers and a public study search — facts already footed on the Colombia execution pillar.

Published forms: what INVIMA actually asks you to file

The operative paperwork is form-driven and published on INVIMA’s Investigación Clínica — Dispositivos page. Know which form belongs to which desk:

• ASS-RSA-FM085 — checklist for the prototype-device technical-opinion request.
• ASS-RSA-FM172 — SEDMRDIV technical-opinion request.
• ASS-RSA-FM169 — initial study evaluation completed by the ethics committee.
• ASS-RSA-FM170 — periodic reports.
• ASS-RSA-FM171 — serious adverse event notification.

There is no ambiguity about what to file. There is considerable skill in filing it in a form the SEDMRDIV will not bounce. Read INVIMA’s register of non-approved device studies before you assume a thin protocol will clear on first pass — that register exists specifically to show which defects cost applicants a cycle.

Ethics and site prerequisites (do these first)

A Colombian trial needs a CEI approved by INVIMA and a site holding a current BPC certificate. That certificate is issued to the IPS after INVIMA verifies compliance with Resolución 2378 de 2008 through inspection visits, runs for five years, and requires evidence that the institution is registered under the Sistema Único de Habilitación with authorized pharmaceutical service, clinical laboratory and sample-collection services inside the same habilitación.

INVIMA’s own register of approved research ethics committees places them in Bogotá, Medellín, Cali, Floridablanca and Montería, attached to established IPS and medical foundations. Bogotá, Medellín and Cali are the tier-1 clusters for most device programs. Replacing a site’s ethics committee is a formal BPC modification requiring a new-conditions verification visit and a written transfer plan agreed with sponsor, CRO and both committees. Sponsors who treat CEI selection as an afterthought lose weeks here.

Device dossier sections that stall first patient

Build the Spanish + English pack so CEI and SEDMRDIV see the same investigation story:

1. Protocol with stopping rules, endpoints, and a device description that matches the article you will import.
2. Investigator’s Brochure / preclinical package — biocompatibility, sterilization, animal or bench data appropriate to risk class.
3. Risk management file (ISO 14971) and technical documentation aligned to how you will later defend the product.
4. IFU and investigator training plan for the investigational article.
5. Clinical-trial insurance covering Colombian subjects.
6. Investigator CVs, GCP certificates, financial disclosures.
7. CEI-specific informed consent in Colombian regulatory language — not a U.S. IRB form with a Spanish machine translation stapled on.
8. Site budgets and contracts executed in parallel with review so activation is not the bottleneck after the opinion lands.

For prototype authorization under Article 36, the device may be used only for research and experimentation. Do not put a commercial Registro Sanitario number on the airway bill for investigational units. That pattern burns weeks at customs and contaminates both tracks.

Import is a separate authorization

Article 48(b) of Decreto 4725 de 2005 permits exceptional importation without sanitary registration or commercialization permit where the device is the subject of clinical research authorized in Colombia, subject to a prior opinion from the relevant specialized chamber. Plan CEI approval, the INVIMA concept, and the import authorization as sequential rather than fully parallel steps unless your operator has a documented reason to overlap them.

Medicines sponsors use a different import hook — Article 96 of Decreto 677 de 1995 — and file initial protocol evaluation through Protocolos en Línea (exclusive since 2 January 2020) under tariffs 4070 / 4083. This checklist is the device path; do not paste drug-platform instructions into a device SEDMRDIV file.

Timelines: what is published vs what is not

There is no statutory day-count in force for protocol authorization. The measured figure footed on the Colombia execution pillar is an average of 5.1 months from filing to a definitive INVIMA concept, approving or rejecting, against a stable volume of roughly 90 protocol-evaluation requests a year (ConsultorSalud, June 2025). Five months to a decision is not fast. It is a measured average with a published rejection register behind it, which makes it forecastable.

A clinical-research framework bill filed in the Cámara in August 2025 would introduce tacit approval — 7 calendar days for common-risk and 30 for high-risk research — and would classify first-in-human studies and novel implantable devices as high-risk. It is not law. Do not put that clock in a board slide as if it were already INVIMA practice.

Common mistakes that stall first patient

• Filing Registro Sanitario paperwork as if it were the trial file. Articles 18–19 evaluate marketing authorization. Article 36 / 48(b) evaluate investigation and exceptional import. Wrong petition, wrong desk.
• Skipping CEI / BPC prerequisites. An INVIMA opinion does not cure a site without a current BPC certificate or an unapproved committee.
• Ignoring the non-approval register. INVIMA publishes why device studies were refused, withdrawn, or left pending response. Read it before you invent a “Colombia is unpredictable” narrative.
• Treating import as automatic once the opinion issues. Article 48(b) still needs the specialized-chamber prior opinion and a clean investigational shipping story.
• Assuming post-trial access is mandatory in Colombia. It is not. Resolución 2378 de 2008 and Resolución 8430 de 1993 contain no statutory post-trial supply duty; Res. 8430 allocates only harm-related costs. See the LATAM PTA operator map and our companion post on compassionate use vs post-trial access.
• One workstream for FIH evidence and later commercial registro. Article 18(k) is why the evidence and the registration strategy belong in the same plan — not why they share one submission form.

Drug path in one paragraph (so you do not mix them)

For medicines, Resolución 2378 de 2008 and Protocolos en Línea govern protocol evaluation; adverse-event content and periodicity follow Resolución 2011020764 de 2011 under Article 146 of Decreto 677 de 1995; controlled substances involve the Fondo Nacional de Estupefacientes. Device sponsors should not use drug tariffs or the medicines Protocolos en Línea path as a substitute for SEDMRDIV forms ASS-RSA-FM085 / FM172 and the CEI form ASS-RSA-FM169.

Related reading on bioaccessla.com

• Clinical trial execution in Colombia
• How to run a first-in-human medical device trial in Colombia
• ANMAT trial authorization vs registro (same desk-separation pattern in Argentina)
• FIH without waiting for FDA
• Colombia regulatory guide

Planning an INVIMA device clinical-research file? bioaccess® is a US-headquartered, LATAM-native operator running regulatory submissions, importadora functions and 2–8 °C GDP cold chain across the region. To discuss dossier sequencing for Bogotá, Medellín or Cali — CEI, SEDMRDIV opinion, Article 48(b) import, and optional later Registro Sanitario — contact Julio Martinez-Clark, Co-Founder & CEO, at jmclark@bioaccessla.com or +1 (954) 903-7210. More at bioaccessla.com/roadmap.

Frequently asked questions

What are INVIMA requirements for clinical trial submission for medical devices?

There is no single “INVIMA clinical trial form.” Device programs combine Decreto 4725 de 2005 (Arts. 36 and 48(b) for prototype authorization and exceptional import), Resolución 8430 de 1993 for human-subjects rules, an INVIMA-approved CEI evaluation (form ASS-RSA-FM169), and SEDMRDIV technical-opinion paperwork (ASS-RSA-FM085 / ASS-RSA-FM172), with the site holding a current BPC certificate under the Resolución 2378 de 2008 inspection regime. Registro Sanitario under Articles 18–19 is a later marketing petition.

Is the INVIMA trial file the same as Registro Sanitario?

No. Registro Sanitario is the marketing authorization that lets a device be sold in Colombia. The investigation path authorizes research use and, separately, exceptional import of the investigational article. Class IIb and III sponsors should plan clinical evidence with Article 18(k) in mind, but they should not file the commercial dossier as if it were the trial submission.

Which INVIMA body reviews device research protocols?

The Sala Especializada de Dispositivos Médicos y Reactivos de Diagnóstico In Vitro (SEDMRDIV) issues technical and methodological opinions on device and IVD research protocols. Since Resolución 2022035262 of 20 September 2022, the GICASE group supports that chamber for clinical research.

How long does INVIMA take to authorize a clinical study?

There is no statutory day-count. The measured average footed on our Colombia execution pillar is 5.1 months to a definitive concept (approve or reject). Plan CEI, INVIMA concept and import as sequential critical-path items unless you have a documented overlap plan.

Does every Colombian site need a BPC certificate?

Yes in practice for the institutions that run interventional research under INVIMA oversight. The BPC certificate runs five years and depends on Sistema Único de Habilitación services (pharmaceutical, clinical laboratory, sample collection) inside the same institution. Contracting those services outside the habilitación adds documentation to every BPC modification.

Does Colombia require post-trial access after the study closes?

No statutory PTA mandate. Resolución 2378 de 2008 and Resolución 8430 de 1993 contain no post-trial supply obligation. Voluntary continuity programs can still be run through ethics-committee and informed-consent expectations. Compare that to the ten LATAM countries with binding PTA duties on the operator map.