Authorised representative

Several major schemes cannot issue a certificate to a foreign manufacturer at all. The Eurasian Economic Union requires an applicant registered in a member state; Brazil requires a company holding a CNPJ; the European Union and the United Kingdom each require an economic operator established locally, named in the documentation and reachable by the market surveillance authorities. These are legal appointments carrying real obligations, not mailboxes. Where a client has no local entity we act as that representative, which also means the certificate does not have to be reissued when a distributor changes.

What the appointment actually obliges

In the European Union the obligations of an authorised representative are set out in the legislation and in Regulation (EU) 2019/1020, which requires that for a range of products no product may be placed on the market unless there is an economic operator established in the Union responsible for it. That operator keeps the declaration of conformity and the technical documentation available for the authorities, cooperates with them, and takes action where a product presents a risk. The United Kingdom mirrors the shape through its own responsible person for the UKCA regime.

The Eurasian Economic Union goes further in one respect: the applicant is not merely reachable, the applicant is the holder. The certificate or declaration is issued in the name of a legal entity or individual entrepreneur registered in a member state, and that party carries the obligations of the person who placed the product on the market.

Brazil sits in the same family. Certification runs through a company with a CNPJ, and for the health-regulated categories a locally registered holder is a condition of the registration rather than a convenience.

None of this makes the representative liable for the design. The technical file, the risk assessment and the evidence remain the manufacturer’s, and the representative’s duties run to holding, producing, cooperating and acting. What it does mean is that the appointment is a contract with defined obligations on both sides, and one that a signature block on an invoice does not create.

Why the distributor is usually the wrong holder

Naming the importer as the applicant is the cheapest arrangement on day one and it is what most first projects do. The cost arrives later, and it is structural rather than financial: the certificate is tied to a commercial relationship. The holder is the party the authority deals with, the party that can amend the document, and the party that has to consent to anything being done with it.

When that relationship ends, the certificate does not travel. A new distributor means a new application, frequently new testing where the reports were commissioned in the previous holder’s name, and a gap during which the product cannot be shipped. Manufacturers discover this at the worst possible time, which is when they are already changing distributor because something has gone wrong.

The second cost is negotiating position. A distributor who holds the market access document holds the market. Renewal conversations with a distributor who knows that are different conversations, and the manufacturer has no alternative that does not involve re-certifying from the start.

The third is confidentiality. The technical evidence — the bill of materials, the schematics, the test reports — sits with the holder, and in this arrangement the holder is a company that may also represent a competitor.

What it costs, and where it belongs in a budget

Representation is a recurring annual cost rather than a one-off, and it is the item most often missing from a first estimate. Over three years the combined cost of representation and certificate renewal often exceeds the initial project cost, which is not an argument against it — it is an argument for it appearing in the model at the point the market is chosen rather than at the point the certificate is nearly ready.

It is also the item that most often stops a project at the last step. A file complete, testing done, application ready, and no established entity to name as the applicant — at which point the schedule waits for a company formation or a representation agreement that could have been arranged in parallel from week one.

Who has to be established locally, and as what

The column that matters commercially is the third one. Wherever the local party holds the document rather than merely holding a copy of it, changing that party means re-certifying rather than re-papering.