Twice in the past week a manufacturer asked me the same question in different words. One is a global device business being separated from its parent company, and its Latin American registrations sit with the parent’s local affiliates. The other is a US-cleared, CE-marked manufacturer of hospital disposables whose registrations sit in its distributors’ names, and it wants to add or replace distributors without refiling. Both were really asking one thing: can we move the registration we already have, or do we start over?
The short answer for the four markets where most of our holder work sits (Brazil, Mexico, Colombia and Peru) is that a registration can be transferred to a new holder without re-filing the technical dossier. Every route has one thing in common, though. The current holder has to sign. If the holder will not sign, there is no transfer. There is a new registration, and a gap in supply while you wait for it.
Here is how each agency handles it, and what I tell sponsors to line up before anyone signs.
Brazil: ANVISA transfer of titularidade under RDC 903/2024
ANVISA’s rule is RDC 903/2024, which replaced RDC 102/2016. It allows a transfer of titularidade only as the result of a corporate operation (merger, spin-off, incorporation or succession) or a commercial operation, meaning a contract that transfers an asset or a set of assets. The transfer is purely administrative. The product’s technical and sanitary characteristics are frozen as they were approved just before the operation.
The mechanics are strict:
- The successor files the transfer petition and the predecessor files the cancellation petition at the same time, within 180 days. The clock starts when the corporate act is filed at the junta comercial or when the asset-transfer contract is signed. Petitions filed late are rejected (Article 26).
- ANVISA publishes the new registration number and the cancellation of the old one together in the Diário Oficial da União. The validity date does not change (Article 29). Labels, IFUs and tender files that print the old number have to be updated.
- Products regularized by notificação cannot be transferred (Article 28). The successor has to notify them again. Under RDC 751/2022 that covers Class I and II devices, so for a low-risk portfolio “transfer” really means re-notifying under the new holder.
- The petition carries the successor’s local sanitary license, so the new holder must already exist and be licensed before the 180 days run out.
The same resolution also covers the global transfer of responsibility for a clinical trial. That matters if a first-in-human sponsor is acquired mid-study in Brazil.
For a distributor switch, the commercial-operation route is a contract in which the distributor hands the registration over as an asset. It still needs the distributor’s signature on the contract and on the cancellation petition.
Mexico: COFEPRIS cesión de derechos
In Mexico the transfer is a cesión de derechos, filed as an administrative modification to the registro sanitario under the device-modification homoclave COFEPRIS-2022-022-003. What COFEPRIS checks:
- The registration must be in force or in renewal under Article 190 Bis 5 of the Reglamento de Insumos para la Salud. The current titular must be the party ceding it.
- The cesión contract must be notarized (protocolizado ante fedatario público).
- For foreign-made devices, a manufacturer’s letter of representation must name the new holder.
- You need an updated Spanish label project and the fee under the Ley Federal de Derechos.
- The cesión has to be notified to COFEPRIS within 30 business days.
The trap is the 30-day window. If the commercial deal closes and nobody is ready with the notarized contract and an apostilled manufacturer letter, you are out of time before the paperwork exists. I draft the cesión documents before the deal closes, not after.
Colombia: INVIMA cambio de titular
INVIMA treats a holder change as an automatic modification under Article 30 of Decreto 4725 de 2005, as substituted by Decreto 582 de 2017. It is granted on filing, and INVIMA reviews the documents afterward. The registration must be in force. INVIMA’s published requirements for the cesión document:
- It must state the intention to transfer and to accept the transfer, in one joint document or two separate ones.
- It must be signed by the legal representatives of both the cedente and the cesionario. Only the current titular can cede.
- It must identify the registro sanitario number, the expediente number, the product name and, where relevant, the brand.
Documents signed abroad need the formalities of Article 251 of the Código General del Proceso. The manufacturer’s authorization also has to tie the new holder to the manufacturer. One more limit: the modification route cannot carry a change that affects safety or effectiveness, such as design, materials, energy source or manufacturing process. Keep engineering changes out of the transfer file.
Peru: DIGEMID transfer under DS 016-2011-SA
Article 8 of DS 016-2011-SA says a registro sanitario can be transferred only by its titular, and only to a party that itself qualifies to hold registrations, meaning a company with sanitary authorization as a laboratorio or droguería. The party must also keep the same manufacturing facilities and conditions. The filing needs a legalized or certified (fedateada) copy of the transfer document.
In practice DIGEMID processes transfers grouped by classification, manufacturer and country. Any change requests still pending on the registration should be closed before you file. After the transfer, the new holder’s details and its Director Técnico are updated through DIGEMID’s change procedure.
What I tell sponsors before they sign anything
- Inventory first. List every registration by country with its number, current holder, risk class, expiry and pending changes. Expired or near-expiry registrations change the plan. Mexico wants the registration in force or in renewal, Colombia wants it in force, and Peru wants pending changes closed.
- Get the signature before you need it. Every distribution agreement should carry a cesión obligation: a cooperation clause and, ideally, a pre-agreed form of the transfer document. A distributor who holds your registro and refuses to sign leaves you with a new registration measured in months.
- Stand up the new holder first. The new holder must be licensed in-country, have a technical director where the country requires one, and hold manufacturer letters re-issued in its name, apostilled and translated. Brazil’s 180 days and Mexico’s 30 business days do not pause while you incorporate.
- Do not change the product during the transfer. Brazil freezes the technical characteristics and Colombia blocks safety-relevant changes on the modification route. File the transfer clean and sequence engineering changes afterward.
- Plan labels and stock. Brazil issues a new number. Mexico needs a new label project. Stock already in the channel carries the old holder’s details, so agree with each agency and your distributors on how existing inventory is handled.
- Move post-market duties on day one. Technovigilance and complaint handling follow the holder. The new holder’s contacts should be live the day the transfer is granted, not a quarter later.
For planning, not as a quote: with a cooperative current holder and a licensed successor, a clean transfer in our files usually takes a few weeks to a few months per country. A contested one turns into a new registration on that country’s full review timeline.
Where bioaccess® fits
bioaccess® acts as the independent registration holder in each market. The registration sits with a holder you direct under contract, not in a distributor’s name, and the transfer terms are written into the agreement up front. If you are inheriting registrations from a parent company or pulling them back from a distributor, we start with the inventory and the signature plan.
For the background on why the license should not be the channel, read the independent registration holder strategy. The country holder guides for Brazil, Mexico and Colombia, and the Peru DIGEMID registration guide, cover the first filing. When you are ready to scope a transfer, start at bioaccess® market access.
Julio G. Martinez-Clark, CEO, bioaccess®