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EU Authorized Representative for Ecuador: ARCSA Registration and the MDR Mandate

ARCSA, Ecuador's sanitary regulation agency, keeps a public register of the medical device and reagent registrations it issues. That register is the Ecuadorian market's record and nothing else: Regulation (EU) 2017/745 does not read it. An Ecuadorian manufacturer selling under its own name in the European Union must designate a sole authorized representative under Article 11(1), register in EUDAMED and hold a file a competent authority can read. Spanish helps, because it is a Union language; it does not finish the job. This page sets out what does, and why one mandate with Medex in Türkiye covers the Union and Türkiye together.

ARCSA keeps a register; the Regulation asks for a file

Ecuador's sanitary regulator is the Agencia Nacional de Regulación, Control y Vigilancia Sanitaria, known as ARCSA (controlsanitario.gob.ec). Among the databases the agency publishes is a register of issued medical device and biochemical reagent registrations ("Catastro de Emisión de Dispositivos Médicos y Reactivos Bioquímicos") and a database of products authorized for import by exception. An Ecuadorian manufacturer with a registration in that catastro has a valid national authorisation.

A European competent authority does not consult the catastro and would not act on it if it did. Regulation (EU) 2017/745 contains no provision under which a third-country registration is recognised. What the Union side reads is the technical documentation drawn up under Annex II and III, the EU declaration of conformity, the certificate from a notified body where the class requires one, and the entries in EUDAMED. The ARCSA registration is useful background for that file and nothing more.

The designation requirement, in the Regulation's own words

"Where the manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if the manufacturer designates a sole authorised representative."

Regulation (EU) 2017/745, Article 11(1).

Ecuador is not a Member State, so the sentence applies to a manufacturer in Quito, Guayaquil or Cuenca without exception. The representative must be established within the Union and must have accepted a written mandate:

"‘authorised representative’ means any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer's behalf in relation to specified tasks with regard to the latter's obligations under this Regulation;"

Regulation (EU) 2017/745, Article 2(32).

Established in Türkiye, representative for the Union

"The ’Union market’ refers to the territories of the European Union Member States, and due to the European Economic Area (EEA) is extended to Norway, Lichtenstein and Iceland, and via the Customs Union Agreement to Turkey."

MDCG 2022-16, footnote 1.

Medex is established in Ankara and holds EUDAMED authorized representative single registration number TR-AR-000057550. Under the footnote above, a mandate with Medex covers the Union market, and it covers Türkiye at the same time. For an Ecuadorian manufacturer whose devices also reach Türkiye, the Turkish importer registers them in ÜTS (Ürün Takip Sistemi), Türkiye's product tracking system. That registration is the importer's duty and a separate service from us; it is not inside the representative fee.

Spanish, English and the Article 11(3)(d) question

"in response to a request from a competent authority, provide that competent authority with all the information and documentation necessary to demonstrate the conformity of a device, in an official Union language determined by the Member State concerned;"

Regulation (EU) 2017/745, Article 11(3)(d).

Spanish is an official language of the Union, which gives an Ecuadorian manufacturer an advantage most third-country manufacturers do not have: a Spanish technical file can satisfy point (d) where the Member State concerned determines Spanish. It will not satisfy a German or Dutch authority. We therefore hold the declaration of conformity, labels, instructions for use and the summary sections of the technical documentation in English alongside the Spanish originals, so that any request can be answered in the language the authority names.

Apostille from Ecuador: when it matters and when it does not

DocumentApostille needed?Why
Mandate between you and MedexNoArticle 11(2): valid when accepted in writing by the representative. MDR does not ask for legalisation.
EU declaration of conformityNoA private document drawn up by the manufacturer under Article 19 and held by us under Article 11(3)(b).
Technical documentationNoEvidence, not a public document.
Ecuadorian corporate or signatory document used before a Turkish authorityYesEcuador is a Contracting Party to the Apostille Convention (accession 2-VII-2004, entry into force 2-IV-2005 in the HCCH status table), so an Apostille replaces consular legalisation. A sworn Turkish translation is added.

The label and the importer's check

"if the manufacturer has its registered place of business outside the Union, the name of the authorised representative and address of the registered place of business of the authorised representative;"

Regulation (EU) 2017/745, Annex I, Section 23.2(d).

The artwork that carries your ARCSA registration number for Ecuador carries, for the Union, the name and registered place of business of the representative. The Union importer looks for it:

"a manufacturer is identified and that an authorised representative in accordance with Article 11 has been designated by the manufacturer;"

Regulation (EU) 2017/745, Article 13(2)(b).

Registration sequence

  • You register as a manufacturer in EUDAMED; the competent authority verifies the data and issues your SRN (Article 31(2)).
  • We record the mandate against our actor record and yours; see EUDAMED registration.
  • Devices are registered under their Basic UDI-DIs beneath the mandate.
  • The registered data is confirmed one year after submission and every second year thereafter (Article 31(5)).

Medex is an authorized representative under Article 11 and nothing else in the chain. We are not a notified body: a notified body is, in the words of Article 2(42), "‘notified body’ means a conformity assessment body designated in accordance with this Regulation;" and only such a body can issue the certificate a class IIa, IIb or III device needs. We are not your importer or distributor either; the importer is the Union entity that physically places your consignment on the market, and that role carries its own duties under Article 13.

Fees are listed on our pricing page: "Fees from EUR 800 a year, no setup fee, one mandate." and "Fees are in euros, exclude VAT, and are fixed for three years from signature."

Other Latin American files: Colombia, Brazil and Mexico.

Frequently asked questions

Our device has an ARCSA registration. Does that help with CE marking?

No. ARCSA registration authorises the Ecuadorian market. Regulation (EU) 2017/745 has no reliance route for it. CE marking follows from technical documentation against Annex I and, above class I, a notified body certificate.

Ecuador is in the Apostille Convention. Do we need an Apostille on the mandate?

No. The mandate is valid when the representative accepts it in writing under Article 11(2). An Apostille issued in Ecuador is used only where an Ecuadorian public document is presented to a national authority, for example in Türkiye.

Can our Spanish-language technical file stay in Spanish?

Spanish is an official Union language, so Article 11(3)(d) can be met in Spanish where the Member State concerned determines it. In practice we hold the declaration of conformity and the core of the file in English as well, so that any competent authority can be answered without delay.

Does one mandate cover Türkiye as well as the European Union?

Yes. MDCG 2022-16 states that the Union market extends to Türkiye via the Customs Union Agreement, so one representative established in Türkiye covers both for the generic device group named in the mandate.

Will Medex import our products into Europe?

No. The importer is the Union entity that places the device on the Union market, defined in Article 2(33), with its own obligations under Article 13. Medex is the authorized representative only.

Send us the ARCSA catastro entries for your devices and the Spanish declaration of conformity, and we will return the mandate draft and the list of documents we need in English. Request a proposal.

Sources and further reading

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