The role
This role already exists. In Europe it has a name, and here it does not.
A manufacturer established outside the European Union cannot simply place products on that market. It appoints an economic operator established inside the EU, an authorised representative or responsible person, and that entity carries a defined set of duties toward the authorities.
Brazil imposes substantially the same duties. It arrived at them from a different direction, through compulsory certification, telecommunications homologation, health surveillance and a consumer statute from 1990, and it never gathered them under a single title. That is the whole reason a manufacturer who handles Europe competently can still arrive here unprepared: there is no word to look up.
The two systems
The same obligations, under different instruments.
| Obligation | European Union | Brazil |
|---|---|---|
| A local legal entity must exist | Authorised representative or responsible person established in the EU | Registration holder, homologation applicant resident or constituted in Brazil, importer of record |
| Point of contact for authorities | Named in the EU declaration and on the product or packaging | The holder of the registration or homologation; in practice the party the regulator writes to |
| Technical documentation kept available | Held for a fixed retention period and produced on request | Held by the certified supplier and produced at audit and surveillance |
| Registration in a public database | Sector databases, depending on the product | Public INMETRO registration base, ANATEL homologation base, ANVISA registration |
| Labelling and language verification | Marking and instructions in the languages of the member state | Information in Portuguese, correct, clear, precise and conspicuous, under the consumer statute |
| Post-market duties and recall | Cooperation with market surveillance and corrective action | Duty to notify authorities and consumers on learning of hazard after market entry |
| Liability for defect damage | Attaches to the producer and, in defined cases, the importer | Importer answers regardless of fault, alongside the foreign manufacturer |
Instruments and articles are listed on the sources page. This table compares the shape of two systems; it is not legal advice on either.
Where the two systems genuinely differ
Three differences that decide projects.
Foreign certification does not carry over
Brazil does not recognise a foreign certificate as a substitute for its own. The testing and the certification are done again, to the Brazilian ordinance, through a body accredited here. A CE marking is not an argument; it is not even a starting position.
The registration is an asset, and it is not yours
In the EU the mandate is a contract you control and can move. A Brazilian registration is issued to the local party. When a distribution relationship ends, the registration does not automatically follow the brand, and reconstructing one takes months.
There is no single regulator to ask
One machine can touch compulsory certification, telecommunications homologation and health surveillance at the same time, each with its own ordinance, its own holder concept and its own deadline. Nobody hands you the combined list.
What the public register shows
The arrangement is already there, in the data.
In one compulsory certification register we read in full, the only foreign brand present does not hold a registration in its own name. It appears as a manufacturer behind a Brazilian holder. That is the shape of every route into this market: the brand is foreign, the responsible party is local.
We name no company here, and we will not name one to you about a competitor either. The point is the shape, and the shape is not a theory we are selling. It is what the register contains.