Before You Sign with a Distributor: Who Controls Your Medical Device Registration in Central America & the Caribbean?
By Naiomi Chardón, Co-founder & VP of Marketing and Commercial Strategy, Rebexa Group.
You’ve found a distributor you like in Costa Rica, or the Dominican Republic, or Panama. The relationship feels right. The contract is almost ready to sign.
Here’s the question most manufacturers don’t ask until it’s too late: whose name is going on the sanitary registration?
Because that name , not the distribution agreement , is what actually controls your ability to sell in that market, communicate with the Competent Authority (CA), and leave the relationship if it stops working.
Why this matters more than the contract
A distribution agreement governs the commercial relationship, but not the regulatory one. In most of the region, whoever is named as the registration holder (or legal representative, which depends on the market) is the party recognized by the health authority. Some responsibilities of that party include:
- Receives CA communications and safety alerts
- Is responsible for pharmacovigilance and adverse-event reporting
- Controls the dossier , the technical file, test reports, labeling approvals
- Decides, in practice, whether the registration moves with you if you change distributors
If your distributor holds that registration and the relationship ends badly, you don’t just lose a sales channel. You can lose your legal right to be on the market at all, while a new registration works its way through the same authority , sometimes for months.
Does this sound familiar? A lot of manufacturers find out how this works only when they’re already trying to switch.
Who can hold what, market by market
This is where it gets specific, because the roles , and who’s allowed to fill them , aren’t the same everywhere.
| Market | Registration holder |
|---|---|
| Costa Rica | The holder must be a locally established entity |
| Dominican Republic | The holder must be a locally established entity |
| Panama | The holder must be a locally established distributor |
The checklist to run before you sign anything
Before your distribution agreement goes final, get clear, in writing, on:
- Who is named as registration holder, and who proposed it. If it’s the distributor’s standard template, that’s not neutral , that’s their default.
- Dossier access. Can you get a full copy of your own technical file and test data at any time, not just on request?
- Regulator communication rights. Are you copied on correspondence with the health authority, or do you find out secondhand?
- Vigilance obligations. Who reports adverse events, and on what timeline, if something goes wrong with your device in that market?
- Exit and transfer terms. What happens to the registration if the distribution agreement ends?
What a clean distributor change actually looks like
When the registration sits with the right party from the start, changing distributors is a commercial decision, not a regulatory emergency: you notify the authority of the new commercial relationship, the registration stays in place, and the new distributor starts selling against an active registration on day one.
When it doesn’t, a distributor change becomes a re-registration , full technical review, new timelines, and a market gap while it processes.
The difference between those two outcomes gets decided before you ever sign, not after you need to change course.
FAQs
Can my distributor hold my medical device registration in Costa Rica?
Yes, under Costa Rica’s RTCR 505:2022 framework. Nevertheless, permitting a distributor to retain title ownership poses considerable risks to strategic alignment and operational efficiency.
What’s the difference between a registration holder, legal representative, importer and distributor in Latin America?
The registration holder is who the health authority recognizes as responsible for the product on the market. The legal representative, where the role exists separately, is the manufacturer’s recognized local contact. The importer physically brings the product into the country. The distributor sells it. One party can hold more than one of these roles , the risk is when the role that matters most ends up with the party you have the least control over. Learn more here.
How do I change distributors without losing my registration?
Confirm, before you sign your first agreement, that the registration sits with you or with an independent party , not with the distributor by default. If it already sits with your current distributor, talk to us about what a transfer looks like before you start that conversation with them.