Sponsors treat Latin American first-in-human logistics as a courier problem. That is why first-patient-in slips after every approval is already “done.” Ethics and INVIMA, ANVISA, or COFEPRIS can be green. The device is still on a dock because nobody decided who is the importer of record.
For an investigational implant or catheter, IOR is a regulatory role. It is the legal person who brings the unit into the country, presents the import license or equivalent, and owns the discrepancy if customs, the health authority, or the site says the serial numbers do not match the dossier.
IOR is not the same as the registro holder
Market access uses an in-country holder or authorized representative for a commercial sanitary registration. A first-in-human study uses an investigational import path. Mixing them is how commercial teams get asked for a trial license, and how FIH teams get asked for labeling they do not have yet. Decide the trial IOR on the protocol’s critical path. Decide the commercial holder when you are ready to sell. They can be the same company. They should never be an afterthought in the freight booking.
What actually stalls FPI
- The CRO assumed the site would import. The site assumed the sponsor’s courier would. Customs assumed a local license holder existed.
- The packing list does not match the ethics or regulator file: quantity, serials, accessories, or “for investigational use” language.
- A distributor offered to import because they import commercial SKUs. Investigational product is a different trámite. Using the commercial channel can strand the units or taint the later registro.
What to lock before you ship
Name the IOR in the same week you pick the country. Put that name on the import authorization, the insurance, and the site’s receiving SOP. Reconcile serials against the protocol’s device accountability log before the box leaves the US. If you cannot explain who presents the documents at the airport, you do not have an activation date. You have a hope.
Colombia, Panama, Mexico, and Brazil will each ask for a slightly different paper. The constant is this: the person who can legally import the investigational device is part of study start, not part of the logistics appendix.