By Julio G. Martinez-Clark
CEO, bioaccess®
General information, not legal, customs or regulatory advice. Official clocks are cited to the regulation or the agency’s own page; each country row links the source. Durations marked “bioaccess® experience” come from our recent study timelines and import trackers. They are planning estimates, not legal deadlines or guaranteed turnarounds. Fees, duties and broker charges are not listed where we could not find an official figure; those cells say “confirm with us”. Sources last checked: 29 October 2026.
In this guide: The short answer · How import works everywhere · Timeline · Country table · Our observed lead times · The US export step · Importer of record · Documents · Fees and costs · What slows import · Checklist · Glossary · FAQ
The short answer
In the Latin American countries in this guide, an investigational drug or device enters under a research import authorization tied to the trial, not under a commercial import. The product and quantities must match the approved protocol. Three roles need a name in each country: the applicant who files the permit, the importer of record who is responsible at customs, and the customs broker. Sometimes one company does all three; the rules differ by country.
Official permit clocks are short once the file is complete. They range from about 48 hours in Argentina and 3 business days in Peru to 15 business days in Panama and 30 business days in Brazil (drug trials). The real lead time is longer: the US export step, the shipment, customs release and, in some countries, an inspection come on top. bioaccess® experience: in Panama, one device shipment reached the sites about 2 weeks after the permit request. In El Salvador, laboratory kits took 38 days from the inventory declaration to the site, and our device plan allows about 69 working days (roughly 3 months) for the permit, shipment and device inspection together.
The fix is sequencing. Name the applicant, importer of record and broker when you choose the country, prepare the import file during the submission, and file the moment the country allows it. In Brazil (drug trials) the import document can be issued before approval, and in Argentina the request can be filed before the final approval. Filing early does not authorize use before approval.
How trial import works in every country
The mechanics differ, but the logic is the same in drug and device trials:
- The trial is authorized first (or, in Brazil and Argentina, the import is filed alongside the trial application). The import authorization refers to the trial.
- The applicant files a research import request with the health authority: typically a product list, quantities, lots, an invoice or proforma, labels and the approval reference. Each country’s list differs (see the table).
- The authority issues a permit (or a “visto bueno”, certificate or import document), often through the country’s single foreign-trade window (VUCE in several countries).
- The product ships with the permit, clears customs as a research import, and is received and stored under the protocol’s conditions.
- Some countries add a step after arrival: Chile needs a “use and disposal” authorization once the product reaches the authorized warehouse, and El Salvador may inspect devices.
Quantities, names and lots must match the approved protocol and the permit. In our recent trackers, document rounds, not the authority’s clock, drove the delays (bioaccess® experience).
Where import sits in the startup timeline
| Step | When to start | Typical duration |
|---|---|---|
| Choose the importer of record and the customs broker | When you choose the country | Before the submission goes in |
| Build the product list, labels, invoice or proforma | During the submission package | In parallel with the submission |
| Trial approval (ethics and regulator) | After submission | See the site activation guide |
| File the import permit | As soon as the country allows; with the trial filing in Brazil and Argentina | Official clock: about 48 hours to 30 business days (table below) |
| US export step (if the product ships from the US) | Alongside the permit; a device export request needs the importing country’s approval letter | Depends on product type (see below) |
| Ship, clear customs, deliver to the site | After the permit | 10 days from Miami to the sites in one Panama study; 6 days from permit to site in one El Salvador import (bioaccess® experience) |
| Post-arrival step (Chile authorization, device inspection) | On arrival | 3 business days in Chile. In El Salvador, our device plan allows about 69 working days for permit, shipment and inspection together (bioaccess® experience) |
Country by country: permits, importer and official clocks
Each row links the official source. The “who” column shows who the source says files, signs or is named on the paperwork. That is not always the same as the customs importer of record; where the source does not say, the row says “confirm with us”. Colombia note: bioaccess® runs first-in-human studies in Colombia now.
| Country and authority | Import document | Who files, signs or is named | Key documents | Official clock | Source |
|---|---|---|---|---|---|
| Argentina: ANMAT | Import authorization requested with the trial application (“12 puntos” form) | A firm enabled by ANMAT; the form is signed by its technical director | 12-point form in duplicate matching the names and quantities in the authorizing disposition, disposition copy (or proof the trial file was opened), fee, commercial invoice, air waybill | Ready about 48 hours after filing | ANMAT procedure |
| Brazil: ANVISA | One Documento para Importação per drug development dossier (DDCM), then the import licence in the Portal Único | Confirm with us | Trial dossier (DEEC) filing; commitment not to distribute the product before the approval is published in the official gazette (DOU) | Drug trials: up to 30 business days after the trial dossier is filed, and it can be issued before approval. One document covers all trials under the same DDCM, and it does not itself authorize the trial | RDC 945/2024 · ANVISA import codes |
| Chile: ISP | Certificado de Destinación Aduanera (customs destination certificate), then a “use and disposal” authorization after arrival | Confirm with us | CDA request citing the ISP provisional-use resolution | 3 business days for the certificate; 3 business days for use and disposal after arrival is notified; provisional-use authorization valid 1 year | Res. Exenta 5161 · ISP CDA procedure |
| Colombia: INVIMA | First import approved inside the protocol evaluation (form FM052); then an import licence (visto bueno) in VUCE | Sponsor or CRO | FM052 product list (drugs, supplies, devices and reagents); later imports: new FM052 plus fee | First import decided with the protocol (no separate clock); later imports: confirm with us | INVIMA guide ASS-RSA-GU036 |
| Costa Rica: CONIS | Desalmacenaje (customs release) authorization for research products, issued in VUCE | Drugs only through a registered drug distributor (droguería); request endorsed by the ethics committee | CEC approval, CONIS registration, product list and quantities | CONIS reviews within 5 calendar days; one correction round of 10 business days | Decree 44033-S amending 39061-S |
| Dominican Republic: DIGEMAPS | Customs authorization for clinical-trial products, through VUCE | The invoice must be in the name of the principal or national investigator; importer of record: confirm with us | Commercial or proforma invoice, current CONABIOS approval, investigator ID, establishment licence | No trial-specific clock published; confirm with us | WTO import-licensing notification |
| Ecuador: ARCSA | Import authorization for investigational product (medicines or natural products, placebos, devices), comparators and complementary supplies, for a trial ARCSA has authorized | Sponsor or its legal representative (the CRO) | Request form (Annex 7 for investigational product; Annex 8 for comparators and supplies), manufacturer’s lot quality certificate with storage and dates, stability data if not registered in Ecuador, original invoice with sender, consignee, product, lot, quantity and value, label as imported | Pay the fee within 10 business days of the payment order; resolution within 15 business days after payment is verified; up to two rounds of 10 business days to correct observations, or the file is cancelled | ARCSA import procedure |
| El Salvador: SRS | Inventory declaration stamped by the SRS clinical-trials unit, then a special import permit requested on the SRS portal | Confirm with us. For context, SRS’s commercial-import rules limit pharmaceutical imports to registered establishments | SRS inventory declaration form; other documents: confirm with us | No clock for trial imports in the sources we found. SRS told us in a 2026 meeting that the permit takes about 1 week once the file is complete (bioaccess® experience) | SRS inventory declaration form |
| Guatemala: MSPAS | Import permit for clinical-trial medicines (DRCPFA) | The person responsible for the authorized protocol signs | Invoice with 12 data points per product (including lot and expiry); two copies signed in blue ink and stamped; letter with the protocol authorization number; proforma invoices not accepted | No clock on the form; confirm with us | MSPAS import requirements, item 8 |
| Mexico: COFEPRIS | Import permit for unregistered drugs for research in humans (COFEPRIS-01-010-A) or for devices without registration (COFEPRIS-01-015) | Confirm with us | Protocol authorization (COFEPRIS-04-010) and product details | 10 business days each | Official response times · COFEPRIS online system |
| Panama: MINSA (DNFD) | Import authorization from the National Directorate of Pharmacy and Drugs | Confirm with us; in our recent study a broker filed it (bioaccess® experience) | RESEGIS registration, ethics approval, GMP certificate, certificate of analysis, investigator’s brochure, pharmacy manual; labels in Spanish | DNFD responds within 15 business days | Executive Decree 21 of 2026, Arts. 95–99 |
| Peru: DIGEMID | Import authorization for investigational and complementary products, through VUCE | Sponsor or authorized investigator | INS trial authorization, detailed product list, exporter proforma with transport route, sworn statement of no re-export; controlled substances also need an Official Import Certificate | Free; up to 3 business days. The official page reports the online service disabled since 20 August 2026; confirm the current channel with us | gob.pe procedure |
| Uruguay: MSP | Participant-level exceptional entry of unregistered medicines for study participants (not a sponsor-level trial import permit) | Sponsor-level route: confirm with us | Forms FO-13221-019 and -020 plus the protocol, emailed to the Pharmacovigilance Unit | No review clock stated; the authorization is valid 30 business days | MSP instructions IN-13221-043 |
Notes on the table.
- Peru: on 29 October 2026 the official page said the service has been disabled since 20 August 2026, that its information is being updated, and asked applicants to confirm fees and requirements by phone at (01) 631 4300. Confirm before you plan.
- Devices: most rows are written for drugs and trial supplies. Device coverage is explicit in Mexico (COFEPRIS-01-015) and in Colombia’s FM052 list, which includes devices and reagents. Brazil runs device trials under RDC 837/2023; confirm the import document for a device study with us. For the other countries, confirm the device route with us.
- Canada, for comparison: the Health Canada No Objection Letter travels with the drug shipment; importers are authorized by the sponsor and listed in Appendix 1 of the application form, and investigators may act as importers (CTA guidance, 2.7.5). For devices, the Letter of Authorization is the legal authorization to import the authorized number of devices (ITA guidance, 2.3.6).
What we have seen in practice
These are real durations from our recent study trackers and plans (bioaccess® experience). They include the steps the official clocks leave out.
| Country | What happened | Duration |
|---|---|---|
| Panama (device study, 2026) | The broker filed the import permit with the proforma. The permit came back about 3 days later; our plan had allowed 10 business days. The product shipped from Miami and reached the sites 10 days after shipping. | About 2 weeks, permit request to sites |
| Panama (plan) | Import workstream run alongside the ethics and MINSA review | About 38 days, in parallel |
| El Salvador (laboratory kits, 2026) | Inventory declaration filed, stamped by SRS 4 days later; permit requested on the SRS portal; one round of observations, answered twice; permit issued; delivered to the site 6 days later. | 38 days, declaration to site |
| El Salvador (device plan) | Import permit, shipment and SRS device inspection | About 69 working days, the longest import step in our plans |
Two lessons from these trackers. First, in El Salvador the round of observations took about two weeks from the observations to the permit; the authority’s clock itself was short. Second, the authority’s holidays and closures count. Build them into the plan.
The step sponsors forget: leaving the United States
If your product ships from the United States, the US export step depends on the product.
| Product | US rule | What it means |
|---|---|---|
| Investigational device going to a Latin American country | Export needs FDA approval under section 801(e)(2) of the FD&C Act (FDA; 21 CFR 812.18) | The export request includes a letter from the importing country’s government approving the import. FDA does not recommend sending safety data if the device has an FDA-approved IDE (or a US IRB non-significant-risk decision) for the same use. Keep export records; FDA has proposed at least 5 years. |
| Investigational drug going to a Latin American country | Export under an IND in effect, where each person receiving the drug is an investigator in a study allowed under the IND; or, subject to its conditions, a certification emailed to FDA’s Office of Global Policy and Strategy when the drug is first exported (21 CFR 312.110(b)) | The certification route needs no FDA approval, but you must meet its conditions and keep records showing compliance. Confirm with us which route fits. |
| Product going to Canada | Canada is on FDA’s tier-one list for devices and on the listed countries in 21 CFR 312.110(b) for drugs; no Latin American country is on these lists | A device can go to Canada without FDA export authorization if it meets the export conditions and Canada’s laws. |
Who can be the importer of record
The importer of record is the legal person responsible for the import declaration and the import obligations. For a trial, that is a regulatory role, not a freight task.
- Some countries say who files or signs. Argentina requires an ANMAT-enabled firm, with the form signed by its technical director. Costa Rica allows drug imports only through registered droguerías. Peru names the sponsor or the authorized investigator as applicant. In the Dominican Republic the invoice must be in the principal or national investigator’s name; who acts as importer of record there: confirm with us.
- Some countries let the sponsor or its CRO file. Colombia and Ecuador name the sponsor or the CRO as applicant.
- Filing is not always the same as importing. The applicant on the permit, the person who signs, the name on the invoice and the customs importer of record can be different. Confirm all four for each country.
- The importer of record is not the registration holder. A commercial registration holder sells approved products. A trial importer brings in unapproved product for the protocol only. They can be the same company, but the processes are different. See importer of record vs registration holder.
In bioaccess® practice we confirm the importer of record for each country at the start, put that name on the permit, the insurance and the site’s receiving procedure, and use a broker who has cleared research imports before. More detail: importer of record for multi-country trials.
Documents to prepare before the first shipment
| Document | Why it matters | Notes |
|---|---|---|
| Final product list: names, codes, quantities, lots, serial numbers for devices, expiry | Must match the approved protocol and the permit | Justify any spares in the protocol quantities; file resupply as a new request where the country requires it |
| Commercial invoice or proforma | Customs value and identification | Guatemala does not accept proformas and lists 12 data points per product; Peru asks for the exporter’s proforma with the transport route |
| Investigational labels | Several countries require Spanish labels (Panama, Chile) | Panama accepts English only by exception |
| Drug quality documents | Requirements differ by country | Panama: GMP certificate and certificate of analysis. Ecuador: lot quality certificate and stability data. Others: confirm with us |
| Trial approvals: ethics and regulator, with reference numbers | The permit cites them | Brazil and Argentina allow filing before approval |
| US export paperwork | Device export approval or drug export certification | See the US export table |
| Cold-chain and temperature records | A customs hold can put a temperature range at risk | Agree the receiving procedure with the site |
| End-of-study plan for unused product | Unused and explanted units need a documented route | Routes differ: Peru asks for a sworn no-re-export statement, so confirm the route per country |
For device accountability through the study, see investigational device accountability in a first-in-human study.
Fees, duties and broker costs
| Cost | What we found | Status |
|---|---|---|
| Health authority fee | Peru’s DIGEMID import authorization is free. Ecuador’s ARCSA import authorization fee is US$150.24. Colombia charges a fee per later import request (amount: confirm with us). Argentina’s form requires a fee (amount: confirm with us). | Official where stated |
| Import duties and taxes | Depend on the product’s customs classification and on any research exemption | Confirm with us |
| Customs broker and forwarder | Vary by country, product and number of shipments | Confirm with us |
| Cold chain, storage and depot | Depend on temperature range and study length | Confirm with us |
We do not publish broker or duty estimates because they change with the product classification and the shipment plan. We quote them per study.
What slows import and how to prevent it
| What slows it | How to prevent it |
|---|---|
| No one named as importer of record | Decide it when you choose the country |
| Product list on the permit does not match the approved protocol | Build the list once, from the protocol, and reuse it everywhere |
| Proforma or invoice missing required data | Use the country’s checklist (Guatemala lists 12 items per product) |
| Labels not in Spanish | Agree label text during the submission |
| US export step not started | Start the device export request or drug certification with the permit |
| Observation rounds on the permit | Answer the same day; in our El Salvador tracker, the round took about two weeks from observations to permit (bioaccess® experience) |
| Holiday closures at the authority | Check the authority’s calendar before you set a ship date |
| Device inspection on arrival | Plan the inspection date with the site and the authority |
| Hand-carrying product | Don’t plan on it. Import in these countries is tied to a research authorization; a unit that enters outside it has no import record for device or drug accountability. Confirm with us before any exception |
| Ancillary items (laptops, printed materials, measuring tools) caught by other agencies’ rules | List every item you plan to ship before submission and buy locally where you can; an industry review flagged this for Argentina and Chile (Applied Clinical Trials, 2017) |
Import readiness checklist
- ☐ Importer of record named for each country, with a signed agreement
- ☐ Customs broker experienced with research imports engaged
- ☐ Product list (codes, quantities, lots or serials, expiry) matches the protocol
- ☐ Invoice or proforma meets the country’s data requirements
- ☐ Labels approved, in Spanish where required
- ☐ Certificates (analysis, GMP, stability) ready for drug shipments
- ☐ Trial approval references ready, or pre-approval filing used where allowed
- ☐ US export approval or drug export certification done
- ☐ Temperature range, packaging and site receiving procedure agreed
- ☐ Post-arrival step booked (Chile authorization, device inspection)
- ☐ Resupply and return or destruction plan agreed
Glossary
- Importer of record (IOR): the legal person responsible for the import declaration and import obligations in the country.
- Customs broker: the licensed agent who files the customs declaration for the importer.
- VUCE: single foreign-trade window; the online system several countries use to issue permits.
- Visto bueno: an approval stamp from the health authority on an import licence.
- Desalmacenaje: release of goods from customs storage (Costa Rica).
- CDA (Certificado de Destinación Aduanera): Chile’s customs destination certificate from ISP.
- DDCM / DEEC: Brazil’s drug development dossier and the trial-specific dossier filed under it.
- Proforma: a preliminary invoice used to request permits before the final invoice exists.
- 801(e)(2) export request: FDA approval needed to export an unapproved investigational device to any Latin American country (none is on FDA’s tier-one list).
- Tier-one country: FDA’s short list of countries with simplified export routes.
Frequently asked questions
Do I need the trial approved before I can import?
Usually yes; the permit refers to the approval. For drug trials in Brazil, ANVISA can issue the import document within 30 business days of the trial filing, before approval, but the product cannot be distributed until the approval is published. Argentina accepts proof that the trial file was opened instead of the final approval.
Who should be the importer of record?
It depends on the country. Argentina requires an ANMAT-enabled firm; for drugs, Costa Rica requires a registered droguería; Peru names the sponsor or the authorized investigator as applicant; Colombia and Ecuador allow the sponsor or the CRO to file. Confirm the applicant and the customs importer of record per country before you submit.
How long does import take?
Official permit clocks run from about 48 hours (Argentina) to 30 business days (Brazil, drug trials). In our experience, one Panama device shipment reached the sites about 2 weeks after the permit request; El Salvador laboratory kits took 38 days from inventory declaration to site; and our El Salvador device plan allows about 69 working days for permit, shipment and inspection.
Is the import process different for drugs and devices?
The logic is the same. Some countries have separate permits for devices, such as Mexico’s COFEPRIS-01-015, and El Salvador may inspect devices. The US export step is also different for devices and drugs.
Do I need FDA permission to ship an investigational device to Latin America?
Yes, for Latin America. Exporting an unapproved device for investigational use to a country that is not on FDA’s tier-one list needs FDA approval under section 801(e)(2), with a letter from the importing country’s government. Canada is on the tier-one list, so export there needs no FDA authorization if the country’s laws are followed.
Do I need FDA permission to ship an investigational drug?
Not always. You can export under an IND in effect, or, if you meet its conditions, send FDA a certification when the drug is first exported and keep compliance records.
Can someone hand-carry product to the site?
Don’t plan on it. Import in these countries is tied to a research authorization, and a unit that enters outside it has no import record for accountability. Confirm with us before any exception.
Are customs duties waived for trial products?
It depends on the country and the product classification. We confirm duties and broker costs per study.
Can I import more than the protocol needs?
Only what the permit covers. Quantities must match the approved protocol and the permit. Justify spares in the first request and plan resupply as a new request where the country requires it (in Colombia, a new FM052 plus fee).
What happens to unused product at the end?
It needs a documented route: return, destruction or another route the country allows. Peru asks for a sworn no-re-export statement, so confirm the route per country. Plan the exit when you plan the entry.
Plan your import with us
bioaccess® runs the import workstream as part of study startup across the Americas: importer-of-record setup, permits tied to the approval, product lists, US export paperwork and resupply. Contact bioaccess®.
Related reading: Site activation timeline in Latin America · Importer of record for multi-country trials · Importer of record vs registration holder · Device accountability in a first-in-human study · Where to run a first-in-human study · Clinical trial budget by country, line by line
Sources
- Argentina: ANMAT, clinical-research import procedure (12 puntos)
- Brazil: ANVISA RDC 945/2024; ANVISA import codes for research
- Canada: Health Canada CTA guidance; ITA guidance
- Chile: ISP Res. Exenta 5161; ISP CDA procedure
- Colombia: INVIMA ASS-RSA-GU036
- Costa Rica: Decree 44033-S amending the biomedical research regulation
- Dominican Republic: WTO import-licensing notification G/LIC/N/3/DOM/11
- Ecuador: ARCSA import of investigational products
- El Salvador: SRS inventory declaration form
- Guatemala: MSPAS import requirements F-IP-r-01
- Mexico: COFEPRIS response times (COEPRIS BCS list, 2025)
- Panama: Executive Decree 21 of 2026
- Peru: DIGEMID import authorization
- Uruguay: MSP IN-13221-043
- United States: FDA, import and export of investigational devices; 21 CFR 312.110; 21 CFR 812.18