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EU Authorized Representative for Chilean Medical Device Manufacturers

Chile's Instituto de Salud Pública registers only the medical devices placed under sanitary control by decree: latex and synthetic condoms, surgical and examination gloves, sterile hypodermic needles and syringes, and portable automated external defibrillators. A Chilean manufacturer of almost anything else exports with no home approval to show. The European Union asks for a full conformity file regardless. This page explains the Chilean position, the Union requirement and the Article 11 mandate that links them.

Sanitary control in Chile applies to a short list of devices

The Instituto de Salud Pública de Chile (ISP) handles the registro sanitario of medical devices under sanitary control. The ISP's service description for that procedure cites the Reglamento de control de productos y elementos de uso médico, Decreto Supremo N° 825/1998, and the decrees that bring specific products under control: Decreto Supremo N° 342/2004 for single-use latex surgical gloves, latex examination gloves and latex condoms; Decreto Supremo N° 1887/2007 for sterile single-use hypodermic needles and syringes; Decreto Supremo N° 93/2018 for synthetic male condoms and female condoms; and Decreto Supremo N° 42/2021 for portable automated external defibrillators. The same document cites Article 7 of the Código Sanitario for the three-year validity of the registration.

Outside that list, a device can be manufactured and sold in Chile without a registro sanitario. For an exporter this has an unusual consequence: an orthopaedic implant maker in Santiago may be a serious, ISO 13485 certified company and still hold no Chilean product approval at all, because none exists for its product.

What the Union requires in either case

The Regulation does not distinguish between devices that are controlled at home and devices that are not. Every device placed on the Union market goes through the same gate:

"Prior to placing a device on the market, manufacturers shall undertake an assessment of the conformity of that device, in accordance with the applicable conformity assessment procedures set out in Annexes IX to XI."

Regulation (EU) 2017/745, Article 52(1)

For a Chilean glove or condom maker, the ISP registration is a national decision that carries no weight in a Member State, although the test data behind it can be reused. For the implant maker with no Chilean registration, nothing is lost either, because the Union never asked for one. In both cases the work is the Annex II technical documentation, the EU declaration of conformity, and for Class IIa and above a notified body certificate. The condoms and gloves device pages cover the two product groups most Chilean exporters ask about.

The mandate: sole, written, accepted

"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)

"The designation shall constitute the authorised representative's mandate, it shall be valid only when accepted in writing by the authorised representative and shall be effective at least for all devices of the same generic device group."

Regulation (EU) 2017/745, Article 11(2)

The representative must be established in the Union. The mandate must be in writing, accepted in writing, and must cover at least every device of the same generic device group. MDCG 2022-16 adds that a manufacturer may use different representatives for different generic device groups, but only one for any given group. A Chilean manufacturer with condoms and gloves could, in principle, mandate two representatives; it could not mandate two for its condoms.

Türkiye as the seat of the representative

Medex is established in Türkiye and acts under EUDAMED SRN TR-AR-000057550. The reason a Turkish seat works for the whole Union is the EU-Türkiye Customs Union, which the MDCG guidance states in its first footnote:

"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

The European Commission's Notice to Stakeholders of March 2022 states that a manufacturer established outside the EU and Türkiye needs to designate only one representative, in either territory, to place devices on the market in both. For a Chilean company that also sells in Türkiye, the mandate covers both; the national device registration in ÜTS (Ürün Takip Sistemi), Türkiye's product tracking system, is a separate step Medex also runs.

Documents from Chile: Spanish, apostille and the ÜTS rules

Chilean files are in Spanish. For a competent authority that determines Spanish, the original serves. For any other Member State Medex needs the EU declaration of conformity and the core technical documents in a language that authority determines, which is why Medex asks for an English set alongside the Spanish:

"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)

Chile is a Contracting Party to the Hague Apostille Convention; the HCCH status table records entry into force on 30 August 2016. An apostille is not needed for the Article 11 mandate. It is needed for ÜTS filings in Türkiye: TİTCK's guide TCKKD-KLVZ-03, Article 8, accepts an apostilled original of a foreign certificate, with the apostille from the manufacturer's country or the country of the EU Authorized Representative, or a Turkish consular attestation, or a verifiable e-signed original, with a sworn Turkish translation.

Chilean instruments against the Regulation

ChileMDRCarries across?
Registro sanitario for listed devices (DS 825/1998 and product decrees)EU declaration of conformity (Article 19) and, for IIa and above, certificate under Article 56No
No registration for devices outside the listConformity assessment still required (Article 52)Not applicable; the Union has no exemption list
Three-year validity (Código Sanitario, Article 7)Certificates valid for the period they indicate, not exceeding five years (Article 56(2))Different clocks
ISP as single authority27 Member State authorities, one representative as contact point (Article 11(7))Structure differs
Spanish labellingLabel and IFU in the language of each Member State (Article 10(11)); representative on the label (Annex I, 23.2(d))New label content

EUDAMED and the limits of the mandate

Medex registers as an actor under Article 31, the Chilean manufacturer registers for its own single registration number, and Medex verifies the device registrations under Articles 27 and 29. The mandate cannot carry the manufacturer's core duties:

"The mandate referred to in paragraph 3 of this Article shall not delegate the manufacturer's obligations laid down in Article 10(1), (2), (3), (4), (6), (7), (9), (10), (11) and (12)."

Regulation (EU) 2017/745, Article 11(4)

Medex is not a notified body and does not issue certificates or carry out conformity assessment. Medex is not an importer or a distributor and does not buy, hold or sell devices. The representative, importer and PRRC roles are separate under the Regulation and stay separate in practice. Fees are published on the pricing page: between EUR 800 and EUR 2,000 per year depending on the MDR or IVDR class, with no setup fee, and fixed for three years from signature.

Frequently asked questions

Our device is not on Chile's sanitary control list, so we have no registration. Does that hurt us in the EU?

No. The Union does not ask for a home-country registration. It asks for conformity assessment under the Regulation, an EU declaration of conformity, UDI, EUDAMED registration and a sole representative. A Chilean manufacturer with no ISP registration starts in the same place as one with a full file.

We make nitrile examination gloves with an ISP registro sanitario. What class are they in the Union?

The class is derived from Annex VIII of the Regulation, not from the Chilean decree; the gloves device page explains the Annex VIII reasoning for examination and surgical gloves. A Class I device still needs an EU declaration of conformity, UDI, EUDAMED registration and an Article 11 representative.

Does the mandate need a Chilean apostille?

No. The Regulation requires a written mandate accepted in writing. An apostille is needed only where a document is uploaded to ÜTS in Türkiye; Chile has issued apostilles under the Hague Convention since 30 August 2016.

Can Medex act as our importer as well?

No. Medex acts as representative under Article 11 and does not buy, hold or sell devices. The importer is the EU company that places the device on the Union market, and under Article 13(2)(b) it verifies that a representative has been designated.

How are competent authority requests handled?

Article 11(3)(d) requires the representative to provide the information and documentation demonstrating conformity in the official Union language the authority determines. Medex forwards the request to the manufacturer, assembles the response and translates where the authority's language is not the language of the file.

Sources and further reading

To appoint an EU Authorized Representative for devices made in Chile, send your device list and current documents through the proposal form. Medex replies with the mandate scope, the EUDAMED steps and the published fee band for your device class.

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