Russia requires a local authorized representative, Colombia requires a local legal representative and in practice mostly has local entities hold the certificate, Chile requires a local entity as the holder, and Brazil has the Registration Holder (BRH) – technical issues in overseas registration can be solved through the dossier, but the one decision that cannot be reversed is whose name the registration certificate is held under. This certificate is the ticket to market access through the channel and a bargaining chip at the negotiation table. This article explains the logic for choosing a holding entity from three angles: regulatory differences, risk scenarios and structure design.
I. First Understand the Regulatory Differences: Four Kinds of “Locality” Are Not the Same Thing
Overseas manufacturers cannot be directly held accountable by a foreign regulator – this is a common premise of global regulation. Therefore, major markets generally require a local entity to act as the applicant or registration holder, taking on document receipt, deficiency responses, adverse event reporting, recalls and post-market responsibilities. But the exact form of “locality” varies widely – some markets only require a local authorized representative, some require the certificate to be held in the name of a local entity, and some require both.
| Market | Registration holder requirement | Other mandatory local roles | Cost of changing the holder |
|---|---|---|---|
| Russia (national pathway) | Registration results are entered into the national register; the certificate lists the manufacturer as the main subject, with the local authorized representative acting as the applicant | Authorized representative (must remain valid in the RZN dossier) | Any change means amending the dossier; authorized representative information must be updated before September 1, 2027, otherwise the certificate may be revoked |
| Colombia | Current law allows a foreign manufacturer to be the Titular, but a local legal representative (apoderado) must be appointed to file; in practice, the certificate is mostly held by a local importer or local agent. A 2026 draft proposes to require the Titular to be domiciled in Colombia | Legal representative, importer holding a CCAA | A registration transfer (Cesión del Registro) must be filed; in practice about 3-6 months |
| Chile | The health registration is issued by the ISP, and the holder must be an entity within Chile (a local importer or the manufacturer’s Chilean subsidiary) | Local representative, importer | Handled through the ISP change procedure; the timeline depends on the review |
One perception that must be corrected: the “registration holder” is not the same as the “owner of the registration certificate”. Legal ownership depends on the terms of the power of attorney (POA) and the bilateral agreements, not on whose name is printed on the certificate.
II. Three Models: What Problem Each Solves, and Where Each Costs You
Model 1: Distributor-held registration
The easiest to operate and the cheapest upfront, and also the most common model in overseas registration by Chinese manufacturers. The price: when you change channels, the certificate is not in your hands, and you need the distributor’s cooperation to transfer it or to cancel and re-register; once the partnership breaks down, you may face a deadlock where “goods can enter but the certificate is withheld”, and you may even be asked to pay a “certificate ransom”. This is the most expensive way to save money.
Model 2: Neutral holding by a third-party agency or consulting firm
A third-party local entity with no interest in the channel holds the certificate, and the manufacturer keeps the freedom to change importers and distributors. Its core value is separating the registration certificate from commercial negotiations. The key precondition is that the agreement must clearly state: ownership of the registration certificate, access rights to the dossier, exit and transfer clauses, and handover obligations when the agency changes.
Model 3: Manufacturer-owned local entity as holder
Setting up a wholly owned subsidiary in the target market, or having a group-owned entity hold the certificate, integrates holding, import and settlement, with the strongest control and easier multi-market coordination. The cost is setup and maintenance expenses, plus local tax and employment compliance obligations. It suits companies that have entered the scaled-sales stage, or that plan to use that country as a regional pivot.
How to choose depends on three variables, not on size: 1. Whether the annual sales in a single country can cover the fixed costs of a local entity (usually a threshold in the hundreds of thousands of US dollars); 2. The frequency of product changes – the more frequent the changes, the more critical the holder’s cooperation becomes; 3. Exit cost – if you may change channels or exit the market within three years, choose a structure that allows a low-cost exit. If even one of the three works against you, do not let the distributor hold the certificate.
III. A Self-Check of Seven High-Risk Scenarios
1. You changed distributors, but the certificate is still in their name – the most common loss-of-control scenario;
2. The power of attorney does not limit the scope of authorization – the POA only says “handle the registration”, without ownership and termination clauses;
3. The holder and the importer are separate but the agreement is blank – unclear ownership of import, warehousing and change-filing rights;
4. Changes to registration information were not filed – note the distinction: “automated renewal” does not mean “change exemption”. In Colombia, Class I/IIa renewals can be approved automatically, but changes of address, legal entity, labeling or manufacturing process must still be filed; unfiled changes are carried over into subsequent renewals and become fatal findings during inspections or recalls;
5. Each market fights on its own – different holding entities and different dossier versions across countries, so changes cannot be synchronized and investment is duplicated;
6. The local role goes “missing” or its qualification expires – an authorized representative being deregistered, an expired POA, or an expired importer CCAA (valid for 5 years in Colombia) can all leave the certificate in someone else’s hands and the goods stuck outside customs. This kind of failure does not come from regulatory penalties but from a partner’s day-to-day negligence, so an expiry reminder mechanism is essential;
7. The company is acquired or its equity changes – once the holding entity or the manufacturer’s legal entity changes, most countries require a registration change; during M&A due diligence, “whether the certificate can transfer with the deal” is often overlooked, and only after closing do you find that a new filing is needed.
IV. Structure Design: Four Documents and Three Bottom Lines
1. Power of Attorney (POA)
Define the scope of authorization, the validity period, whether sub-delegation is allowed, termination conditions and post-termination cooperation obligations; it must be notarized and legalized with a Hague Apostille, and translated into the local official language. The validity period must cover the entire certificate cycle (Colombia’s certificate is valid for 10 years, Russia’s has no expiry date), not just the filing period; if an irrevocable authorization can be signed, sign it.
2. Registration Holding Agreement
Define ownership of the registration certificate, ownership of and access to the dossier, and version control of the technical documentation. It is also recommended to agree that: the master dossier is always kept by the manufacturer, and the holder keeps only controlled copies; ownership of regulatory platform accounts (such as Colombia’s SIRIS or the personal RZN account in Russia) and the handover method should be written into an annex.
3. Distribution Agreement
Decouple the certificate from the channel and specify the certificate handover mechanism upon exit, avoiding “the certificate goes where the person goes”. Make clear that “a transfer is a change of registration, not a conveyance of title”: Colombia requires a Cesión (3-6 months), Russia requires amending the dossier, and Brazil requires a new BRH to take over – so the handover clauses must include continued supply and cooperation obligations during the transition period.
4. Change Impact Assessment Mechanism
Establish a process to judge whether engineering changes, supplier changes and labeling changes require a regulatory filing, and execute it in every country in sync.
Three bottom lines that cannot be solved by contract:
1. Statutory responsibilities cannot be outsourced. The responsibilities of the registration holder, authorized representative and importer toward regulators are statutory; agreements can only provide for internal recourse and cannot be asserted against the regulator – the phrase “if something goes wrong, the other party bears it” is void before a regulator.
2. Holding locally brings business substance into the country. Holding and importing through your own entity creates permanent establishment (PE) and transfer pricing issues; with a neutral third party as holder, the pricing of service fees and royalties needs a defensible method. Decide these two points with tax advisors when designing the structure, not at the first annual tax settlement.
3. Responsibility boundaries must be assigned to people. Safety reporting, recall execution and vigilance system operation must ultimately be assigned to specific roles and SOPs; however detailed the agreement, without executors it is as if nothing was agreed.
One-sentence principle: channels can change, but the registration certificate must never slip out of your control. The holding structure must be negotiated in the first round of commercial talks, not signed a week before filing.
V. Multi-Market Coordination: Treat Holding as an Architecture
For companies operating simultaneously in Russia, Latin America (Brazil, Colombia, Chile), the Middle East and other markets, the recommended structure is “unified dossier + distributed holding”: one master version of the technical documentation with country-specific localized derivatives, with holding entities implemented according to each country’s rules, but ownership and change synchronization managed uniformly through group-level agreements. This satisfies each country’s statutory requirement for a local entity while avoiding “one country changes, the others fall out of step”.
There are three implementation points:
1. Build a “change – country – filing obligation” matrix, so that every design or process change is judged country by country for whether and when to file;
2. Keep a unified ledger of certificates and local qualifications in every country (authorized representative, CCAA, AFE, etc.), with expiry reminders, turning partners’ negligence into something you control;
3. Keep the product name, model and intended-use statements traceably consistent across markets for the same product, to avoid rejection over “word-for-word inconsistency” – the most frequent deficiency reason in Colombia.
Closing: the registration certificate is an overseas asset, not a customs clearance document. Design the holding structure well, and all your registration investment truly belongs to you.
Disclaimer: This article is compiled from the publicly available regulatory systems of the respective markets (verified as of October 30, 2026) and does not constitute legal advice. Countries differ in their statutory requirements for registration holders and in the validity of agreements, and some markets (such as Colombia) are in a period of regulatory transition; for contract and liability clauses, advice from local counsel is recommended.