Most US and EU manufacturers treat Latin American registration as a paperwork extension of the 510(k) or CE mark. That is why they lose six to eighteen months after the certificate is already in hand. The scientific file is usually the easy part. The asset that decides whether you can sell — and whether you can change partners — is the in-country holder.
Call it authorized representative, registro holder, or importer of record. In ANVISA, INVIMA, COFEPRIS, ANMAT, ISP, and DIGEMID, the sanitary registration sits in a local name. If that name is your distributor, you do not own market access. You are renting it.
What sponsors get wrong on day one
They sign distribution first and registration second. The distributor files as holder because it is “faster.” It is faster until you want a second distributor, a hospital tender in another city, or an exit. Then the registro is a commercial hostage. Changing holder is not a clerical update. In several LATAM agencies it is a new clock: translations, fees, and a queue that does not care that the device was already cleared in the US.
The other mistake is treating every country as a copy of the FDA file. Classification, Spanish (or Portuguese) tier, local testing, and who may import are country rules. A certified US translation that is not a traducción oficial in Colombia, or a holder that cannot legally import the SKU in Mexico, will bounce the file before a reviewer reads the clinical section.
The holder question to ask before you file
- Who is the legal owner of the registration if we change distributors?
- Can we appoint a new importer without a full re-registration?
- Are government fees, translations, and variations inside one annual structure, or will every country become its own surprise invoice?
- Does the same entity that holds the registro also handle vigilance and renewals, or will that split when the first serious complaint arrives?
Already cleared is a different offer than first-in-human
First-in-human and early feasibility are a clinical-operations problem: ethics, import of investigational product, site activation. Market clearance is a holding problem: keep an already FDA-cleared or CE-marked device legal to sell in LATAM. Mixing the two in one workstream is how FIH teams get asked for commercial labeling they do not have, and how commercial teams get asked for investigational import licenses they should never need.
If the device is already cleared and the goal is to sell, design the LATAM program around holder, translations, and government fees — not around another clinical protocol. The market-access page for that model is the LATAM Launch Subscription: one annual structure for registration and holding across the region, instead of a new distributor-owned registro in every country.
The registration is the commercial asset. Put it in a name you control before the first tender, not after.
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