PRACTICAL GUIDE | 2026

Importing Investigational Devices into Latin America: Formal Importation, Timelines, and the Hand-Carry Trap

Your devices cannot enter on a promise. They enter on paperwork.

By Julio G. Martinez-Clark

CEO, bioaccess®

Last verified: September 2026 | General information only—not legal or regulatory advice. Rules change frequently; confirm the strategy with qualified regulatory counsel.

Publishing package

An investigational device is a medical device that is not yet registered or cleared for marketing in the country where the trial runs. It enters under a research authorization, not a commercial one. That distinction drives everything that follows: the import is tied to the clinical trial approval, limited to the quantities the trial needs, and documented device by device. Importing investigational devices into Latin America is therefore not a logistics task you hand to a freight forwarder at the last minute. It is a regulatory workstream that starts when the submission strategy starts.

This post builds on our earlier guide on the IOR vs Registration Holder: Latin America Medical Device Compliance Guide. That post answered who holds the registration. This one answers how the physical devices cross the border for a trial — the import permits, the timelines, and the hand-carry trap sponsors fall into when the startup clock is tight.

What does formal importation of an investigational device require?

The core package is consistent across the region, with local mechanics on top. Before any shipment moves, the clinical trial itself must be authorized by the national health authority and the ethics committee. The import authorization is then issued in connection with that trial approval — for the named devices, in the approved quantities, for the approved sites.

• A licensed importer of record (IOR). Someone legally responsible for the import must exist in the country. In several LATAM markets the IOR for trial product is the same local entity structure used for registration holding; in others it is a separate licensed importer. Confirm which applies before you ship.
• An import authorization tied to the trial. This is not a commercial import permit. It references the trial authorization and is typically limited to the device quantities in the protocol plus a defined margin for replacements.
• A device-level manifest. Model numbers, quantities, serial or lot numbers, and values for customs. The trial master file should be able to account for every unit that entered, was implanted or used, was returned, or remains in inventory.
• Investigational labeling. Devices must be identifiable as for clinical investigation only, consistent with the approved protocol and labeling submitted to the authority.
• A customs broker who has done this before. Trial-product imports clear under different codes and authorizations than commercial shipments. A broker who only moves commercial freight will slow you down.

How do import permits work country by country?

Mechanics vary. The table below gives the orientation sponsors need to plan — the agency that governs the import, and how the authorization connects to the trial. Procedures change; treat every row as a starting point to confirm with current local procedure, not as a filing instruction.

Market	Import authorization for trial devices	Planning note
Brazil — ANVISA	Two layers: ANVISA approval of the device clinical investigation (RDC 837/2023; the Comunicado Especial lists the investigational products and authorized quantities), plus a Licença de Importação (LI) in Siscomex with ANVISA release at the port of entry. The importer needs AFE (Autorização de Funcionamento). Note: the import rulebook (RDC 81/2008) is under revision — confirm the current instrument before citing it.	Build import lead time into the startup plan from day one; Brazilian import processing is its own critical path.
Colombia — INVIMA	A per-shipment import permit filed through VUCE (MinCIT) with INVIMA visto bueno, after INVIMA approves the protocol; nationalization at DIAN. Each shipment needs its own permit.	Device lists and quantities must match the approved protocol.
Mexico — COFEPRIS	Import permit for research use, connected to the COFEPRIS trial authorization.	Confirm the current COFEPRIS procedure at filing; the agency's processes have been changing (see our COFEPRIS coverage).
Panama — MINSA	Import authorization tied to the trial authorization from the Ministry of Health.	Panama's fast startup clock only holds if the import workstream runs in parallel with ethics and regulatory submissions.
Chile — ISP	Import authorization in connection with the ISP trial authorization.	Coordinate the import filing with the trial submission so devices arrive when the site is ready, not before or months after.
Argentina — ANMAT	Import authorization linked to the ANMAT trial approval.	Argentina's import documentation requirements are exacting; reconcile every document before filing.
Smaller / import-permit-only markets	Where no device registration system exists, a straightforward import permit may be the entire requirement (see our guide to markets where no registration is needed).	Simpler does not mean informal: the permit, the manifest, and the IOR still apply.

Why is hand-carry the trap?

When the startup clock is tight, someone always suggests it: a team member flies down with the devices in a suitcase and the trial starts Monday. Here is why that is the trap, even when it technically gets a unit across the border.

1. It breaks traceability. The trial master file must account for every investigational unit. A device that entered without an import authorization has no clean paper trail — and it breaks ISO 14155 device accountability (lot/UDI, shipping records, chain of custody), which matters if the data is later offered to FDA. An inspector will notice.
2. It risks seizure. Customs officers see undeclared medical devices, not clinical urgency. A seized shipment at the airport delays the trial far more than a planned import would have.
3. It cannot scale. Hand-carry might move one urgent replacement unit. It cannot move the full trial supply, backups, and the inevitable second shipment.
4. It teaches the wrong lesson. Every successful hand-carry convinces the team that formal importation is optional. It is not. Regulators and ethics committees expect the import authorization to exist.
5. It complicates re-export and returns. Unused and explanted devices often must leave the country under documented procedures. Units that entered informally cannot exit formally.

The narrow exception proves the rule: in a genuine emergency — a replacement unit needed for an enrolled patient — a documented, declared hand-carry with prior local counsel guidance can serve as a bridge while the formal authorization catches up. That is a bridge. It is not a plan.

How do import timelines fold into the startup clock?

Importing investigational devices into Latin America fails most often as a sequencing error. Sponsors treat importation as step five — after trial approval — when it should run as a parallel workstream from the submission phase. The practical sequencing:

1. During submission prep: identify the IOR, confirm the import authorization procedure, and draft the device manifest from the protocol's device list.
2. At trial submission: open the import workstream — engage the customs broker, confirm labeling and valuation requirements, and prepare the authorization application so it can be filed the moment the trial is approved.
3. At trial approval: file the import authorization immediately; do not wait for site initiation to be complete.
4. Before first shipment: verify the authorization covers the exact models, quantities, and consignee. Reconcile the manifest against the approved protocol.
5. During the trial: track every unit in and out. Plan the replacement-device import before you need it.

What should the sponsor prepare before the first shipment?

• Final device list with models, quantities, serial/lot numbers, and customs values.
• Confirmed importer of record with a signed agreement.
• Trial authorization and ethics approval references for the import application.
• Investigational labeling matching the approved protocol.
• Customs broker briefed on trial-product (not commercial) import codes.
• Re-export/return procedures agreed for unused and explanted units.
• A replacement-unit plan: how many spares, and the lead time to import more. Import permits are typically per-shipment and validity varies by country — a permit can expire before you use it, so plan the second import before you need it.

The checklist: importing investigational devices without derailing first-patient-in

1. Name the IOR before submission. Do not discover at shipping time that no licensed entity can receive the devices.
2. File the import workstream in parallel. Import preparation starts with the trial submission, not after approval.
3. Match the manifest to the protocol. Models, quantities, and sites on the import authorization must mirror the approved trial documents.
4. Never plan around hand-carry. One emergency bridge, documented and declared, is the most it should ever be.
5. Account for every unit. Implanted, used, returned, in inventory, re-exported — the trial master file closes only when the device count closes.

Frequently asked questions

Can we hand-carry investigational devices into Latin America for a trial?

At most as a limited, documented bridge for an urgent unit — never as the import plan. Formal importation with an authorization tied to the trial approval is required, and hand-carried units break the traceability the trial master file demands.

Does the import permit depend on the clinical trial being approved first?

Yes. Import authorization for investigational devices is issued in connection with the trial approval. That is exactly why the import workstream must be prepared in parallel with the submission — so the application can be filed the day the trial is authorized.

Who acts as the importer of record for trial devices?

A locally licensed entity in each country. Depending on the market, this may be the same local structure used for registration holding or a separate licensed importer. See our IOR vs Registration Holder guide for the distinction.

How many devices can we import for the trial?

The authorization typically covers the quantities in the approved protocol plus a defined margin for replacements. Importing commercial-scale quantities under a trial authorization is not permitted.

What happens to unused devices when the trial ends?

They must be accounted for — returned to the sponsor or destroyed under documented procedures, often requiring re-export authorization. Plan the exit at the same time you plan the entry.

Do import-permit-only markets still need formal importation?

Yes. A simpler permit is still a permit. The device manifest, the licensed importer, and the paper trail apply even where no device registration system exists.

Move devices across borders without moving your timeline

bioaccess® runs the import workstream as part of every Latin America FIH program: importer-of-record setup, authorization filings tied to the trial approval, device-level manifests, and replacement-unit planning — so importing investigational devices into Latin America never becomes the reason first-patient-in slips.

Talk with bioaccess® about your Latin America FIH strategy

Regulatory references

• Brazil: ANVISA clinical trial and import licensing procedures; confirm current requirements at filing.
• Colombia: INVIMA research import authorization procedures; confirm current requirements at filing.
• Mexico: COFEPRIS research import permit procedures; confirm current requirements at filing.
• Panama: Ministry of Health (MINSA) trial and import authorization procedures; confirm current requirements at filing.
• Chile: Instituto de Salud Pública (ISP) trial and import authorization procedures; confirm current requirements at filing.
• Argentina: ANMAT trial import authorization procedures; confirm current requirements at filing.
• bioaccess® blog: IOR vs Registration Holder: Latin America Medical Device Compliance Guide (2026).
• bioaccess® blog: The Latin American Countries Where You Don't Need a Medical Device Registration (2026).