The quietest way to miss first-patient-in in Latin America is to treat import as a shipping task. Ethics stamped the protocol. The regulator stamped the study. The implanting physician blocked a room. The crate is still in customs because nobody owned the investigational import as its own permit.
Clinical-trial authorization and investigational import are different legal objects. One lets you treat patients under a protocol. The other lets a specific lot, in a specific packaging configuration, cross a border for that protocol. Mixing them with a future commercial registro is how devices sit on a tarmac while the site calendar dies.
What you are actually waiting on
After the CEI / IRB letter, the bottleneck is usually not “more patients.” It is:
- A named importer of record (IOR) who is allowed to receive investigational devices in that country.
- A permit or license that cites the protocol, the device identity, the quantity, and the site — not a commercial sanitary registration number you do not have yet.
- A packing list, invoice, and airway bill that match that permit. “We’ll fix the HS code at the airport” is not a strategy.
- A chain of custody into the investigational pharmacy or device accountability log. If the box lands at a distributor who is your future commercial holder, you have started the wrong file.
The commercial holder conversation — titular versus distributor, who should own the future registro — is a different article. See Titular de registro LATAM vs distribuidor. Do not use the trial IOR as the future registration holder “to save a contract.” Cheap in month one. Expensive when you want a second importer or an inspection.
Four import clocks — trial, not launch
These are first-in-human clocks. They expire with the study. They do not become a commercial entry.
INVIMA (Colombia)
Colombia is often the fastest ethics-plus-regulator pair when the dossier is complete: CEI review in parallel with INVIMA, then an INVIMA-issued import permission tied to the authorized study. The import is not a side errand for the site. If the importer named on the permit is not the entity that will sign the warehouse, the crate waits. Plan the importer identity in the same week you lock the PI, not the week the airway bill is cut. INVIMA home: invima.gov.co.
ANVISA (Brazil)
Brazil’s device-trial pathway (DICD under RDC 837/2023 for the clinical file) still leaves you with a separate import license problem. Investigational entry runs through an import license (licença de importação) and the rules that govern investigational-product importation — sponsors still treat RDC 39 as the operational text they have to satisfy, not a footnote. Portuguese documents, a regularized Brazilian company, and a quantity that matches the protocol. Class I/II device FIH can be CEP-leaning on the clinical side and still fail in customs if the import file is a US commercial invoice. ANVISA: gov.br/anvisa.
COFEPRIS (Mexico)
Mexico is where teams confuse the two DIGIPRiS doors. Protocol authorization is not a Permiso Sanitario de Importación. You need both, and the import permission has to describe the investigational lots. A Mexican legal representative who is ready for a future registro is not automatically the consignee for a protocol-only shipment. If first-patient-in is on a surgical calendar, start the import permission when the CEI pack goes in, not when the surgeon asks where the device is. COFEPRIS: gob.mx/cofepris.
ANMAT (Argentina)
ANMAT’s 2026 trial-authorization conversation (including the 62-day framework sponsors are now planning against) still sits next to an import permission under the investigational-product rules — Disposición 4457 is the text operations teams keep on the wall. Tariff cuts on commercial medical devices do not rewrite an investigational import. HELENA is the commercial desk; it will not undock your FIH crate. ANMAT: argentina.gob.ar/anmat.
Documents that actually move the crate
- Protocol identifier and ethics / regulator authorization numbers on the commercial invoice and packing list.
- Device identity that matches the investigator’s brochure: model, lot/serial, sterile barrier, software version if it is part of the investigational article.
- Quantity that a reviewer can reconcile to the protocol’s sample size plus spares — not a “launch inventory” number.
- Consignee = trial IOR. Notify party = site or CRO. Not your future distributor “so they can learn the product.”
- Temperature, dangerous-goods, and battery declarations written once, used everywhere. Rewriting them at the handling agent is how you miss the implant slot.
Calendar, not folklore
I do not publish a fake “import is always 10 days” number. Agency queues and customs holds are outside any CRO’s control. What is inside your control is sequencing:
- Week 0 with site selection: name the trial IOR. If you cannot name the importer, you do not have a country.
- Same week the CEI pack is submitted: draft the import dossier (invoice template, packing list, authorization citations). Do not wait for the approval letter to invent the paperwork.
- On approval: file import immediately. First-patient-in is a hospital calendar. Import is a permit calendar. They only meet if you started both.
- After last patient: close investigational inventory. Do not “leave the leftover lots with the site for commercial use.” That is a new sanitary-registration and a new commercial import — see the post-FIH sequence.
OUS FIH data can support an IDE or a device marketing submission when the investigation meets 21 CFR 812.28 GCP (IEC review, consent, traceable conduct). Eligibility of foreign clinical data is not FDA clearance. A missing import trail is how you lose device accountability, which is how you lose the GCP story.
Commercial IOR economics are a different contract. bioaccess®’s public LATAM Launch Subscription (USD 7,500 per year per country for the first device family; higher for Mexico Class III / energy and Brazil Class III/IV) is a sanitary-holder architecture, listed on the pricing page. Investigational import is billed and permitted as study conduct. Do not budget them as the same line. Market-access hub: bioaccess® market access.
Three import mistakes I still see after the ethics letter
- Cutting the airway bill to the PI “because he is the investigator.” Unless that person is the licensed importer, customs does not care about the protocol.
- Using a commercial sanitary registration number from a predicate or a cousin SKU. The investigational article is not that product.
- Scheduling first implant on the ethics-approval date plus two weeks, with no import owner. That is a hope, not a Gantt.
This week: one page with four columns — Colombia, Brazil, Mexico, Argentina (or the subset you will actually open) — and four rows: IOR legal name, import-permit type, documents already in Spanish/Portuguese, and the first date a device can physically sit in the site’s accountability log. If quality, regulatory, and the person who signs freight cannot point to the same consignee, you are hoping, not importing.
Disclosure: I am CEO of bioaccess®, a first-in-human / early-feasibility medical-device CRO with US regulatory anchoring and Latin American execution. The import sequence above is how I tell sponsors to put the crate on the calendar; it is not a guarantee of any permit, and it is not a CRO hard-sell. Self-reported ~40% faster / ~30% lower per-patient cost figures used elsewhere on bioaccessla.com are experience since 2010, not a formal study, and they assume the import workstream was actually staffed.