EU Authorized Representative by Manufacturer Country

Chile registers only listed devices with the ISP; most leave with no home approval. For the EU a Chilean maker needs a sole EU Authorized Representative.

A DIGEMID registro sanitario stays in Peru. For the EU a Peruvian manufacturer needs a sole EU Authorized Representative, an EU DoC and EUDAMED registration.

ANPP homologation of dispositifs médicaux stays in Algeria. For the EU an Algerian manufacturer needs a sole EU Authorized Representative and EUDAMED.

Iraqi manufacturers answer to the Ministry of Health at home. For the EU they need a sole EU Authorized Representative, an EU DoC and EUDAMED registration.

Lebanon's MoPH Decision 455/1 registers suppliers and implants. For the EU a Lebanese manufacturer needs a sole EU Authorized Representative and EUDAMED.

Azerbaijan registers devices above risk class I for import. The EU exempts no class: Azerbaijani makers need a sole EU Authorized Representative.

Moldova's AMDM treats CE-marked and non-CE devices differently. The EU needs the CE side done first and a sole EU Authorized Representative. Medex.

Bosnia and Herzegovina is outside the EU. ALMBIH registration is not CE marking. Manufacturers need a sole EU Authorized Representative. Medex explains.

North Macedonia is outside the EU. A MALMED register entry is not CE marking. Manufacturers need a sole EU Authorized Representative. Medex explains.

Albania is outside the EU. AKBPM registers devices under Law 89/2014 on the strength of a DoC or CE. Makers need a sole EU Authorized Representative.

EU authorized representative for Georgia medical device manufacturers: why Tbilisi registration stops at the border, and one mandate for EU and Türkiye.

EU authorized representative for Kazakhstan medical device manufacturers: why Center of Expertise registration stays national; one mandate, EU and Türkiye.

EU authorized representative for Uzbekistan medical device manufacturers: national certification is not CE, Apostille objections, one EU-Türkiye mandate.

EU authorized representative for Jordan medical device manufacturers: JFDA registration stays national, legalisation not Apostille, one EU-Türkiye mandate.

EU authorized representative for Qatar medical device manufacturers: who is the manufacturer under Article 2(30), legalisation not Apostille, one mandate.

EU authorized representative for Kuwait medical device manufacturers: manufacturer, importer and representative roles, Article 11(1) for devices and IVDs.

EU authorized representative for Ecuador medical device manufacturers: ARCSA registration stays national, Spanish and English files, one EU-Türkiye mandate.

EU authorized representative for Uruguay medical device manufacturers: the MSP habilitación is not a device certificate; one mandate for EU and Türkiye.

EU authorized representative for Oman medical device manufacturers: the Drug Safety Center list has no EU equivalent; one mandate for EU and Türkiye.

EU authorized representative for Bahrain medical device manufacturers: NHRA approval stays national, Article 12 handover, one mandate for EU and Türkiye.

EU authorized representative for Ghanaian device makers: how FDA Ghana classes I to IV, the local agent and cGMP registration compare with the MDR.

EU authorized representative for Sri Lankan device makers: NMRA classifies by EU rules, but CE marking, EUDAMED and an Article 11 mandate are still needed.

EU authorized representative for Nigerian device makers: how NAFDAC classes A to D, the 2024 Regulations and the local Power of Attorney compare with the MDR.

EU authorized representative for Moroccan device makers: how Law 84-12 classes, enregistrement and the export free sale certificate compare with the MDR.

EU authorized representative for Kenyan device makers: how PPB classes A to D, reliance routes and the Local Authorized Representative compare with the MDR.

EU authorized representative for Hong Kong device makers: how MDACS listing and the Local Responsible Person compare with MDR, and what to set up for the EU.

EU authorized representative for Argentine device makers: how ANMAT classes I to IV under GMC Resolution 25/21 map to MDR classes, and the EU set-up.

EU authorized representative for Costa Rican manufacturers: why RTCR 505:2022 and free-zone status give no MDR credit, and how to set up Article 11 in EUDAMED.

EU authorized representative for Ukrainian manufacturers: why a Technical Regulation 753 file is not an MDR file, what Resolution 759 changes, EUDAMED setup.

EU authorized representative for Serbian manufacturers: ALIMS accepts CE, but the Union does not accept the Serbian mark. What MDR requires and EUDAMED setup.

EU authorized representative for Tunisian device manufacturers: how DPM import control differs from MDR, what the file needs, and how the Union side is set up.

EU authorized representative for Philippine device makers: how AMDD classes A to D, CMDR and CSDT files compare with MDR, and how the Union side is set up.

EU authorized representative for Colombian device makers: how Decreto 4725 classes, INVIMA registros and BPM certificates compare with MDR, and what to set up.

A 510(k), De Novo or PMA decision from FDA carries no weight under MDR. How US device makers appoint an EU Authorized Representative and close the gap.

An NMPA registration certificate carries no weight under MDR. How Chinese exporters fix classification, Class I self-declaration and legal-manufacturer risk.

India's Medical Devices Rules 2017 and a CDSCO Form MD-9 licence give nothing toward CE marking. EU Authorized Representative for Indian device exporters.

Japan is an MDSAP member; the EU is only an observer. What Shonin, Ninsho, Todokede and MHLW Ordinance 169 give you under MDR, and what they do not.

MFDS notification, certification and approval stop at Korea's border. How Korean dental, aesthetic and IVD exporters classify and certify under MDR and IVDR.

For Taiwan's OEM and ODM plants the first MDR question is who owns the CE mark. TFDA licensing, Article 23 components and Rule 10 monitoring, explained.

Manufacturers in Turkey need no EU-side representative under the EU-Turkey Customs Union; non-EU makers may appoint one in Türkiye. MDR, TİTCK, SRN explained.

Israel's Medical Device Division registers devices on the strength of a CE or FDA approval, which makes your MDR certificate the file everything else rests on.

ANVISA's four risk classes under RDC 751/2022 look MDR-shaped, and MDSAP is real leverage in Brasilia. Neither reaches a notified body's Annex IX audit.

MHRA regulates Great Britain under UK MDR 2002 while EU MDR applies in Northern Ireland. EU Authorized Representative support for British device makers.

Since 26 May 2021 Swissmedic has treated Switzerland as a third country: Swiss makers need an EU Authorized Representative, EU makers need a CH-REP.

Health Canada Class I to IV licences and MDSAP certificates carry only part way into an MDR notified body audit. EU Authorized Representative for Canada.

TGA Essential Principles resemble MDR GSPRs but are separate law, and MDSAP stops at the EU border. EU Authorized Representative for Australian manufacturers.

Medsafe WAND is a notification database, not an approval, so MDR is often a New Zealand manufacturer's first regulator. EU Authorized Representative service.

HSA's abridged route lets an EU notified body certificate shorten a Singapore review. Nothing runs the other way. What a Singapore file gives you in the EU.

Malaysia registers devices under Act 737 through a Conformity Assessment Body. Under MDR examination gloves are class I, surgical gloves class IIa. Here's why.

Decree 98/2021/ND-CP already names a product owner; MDR names a manufacturer. For Vietnamese contract plants building for EU brands, the two must line up.

Thai FDA lists, notifies or licenses a device by risk class. MDR never mentions latex at all - it asks for materials and residue evidence instead. What changes.

Kemenkes izin edar puts an AKL registration in your distributor's hands. MDR keeps every obligation with the manufacturer. EU Authorized Representative service.

Sialkot's reusable surgical instruments are MDR class Ir, so a notified body assesses reprocessing. DRAP enlistment does not. EU Authorized Representative.

Gauze, gowns and drapes are classified by MDR Rule 4 wording, and sterile presentation adds a notified body. DGDA registration does not travel to the EU.

COFEPRIS registro sanitario and its equivalence routes produce no EU declaration of conformity. EU Authorized Representative for Mexican device exporters.

The Egyptian Drug Authority classifies devices under the repealed EU-MDD Annex IX. MDR Annex VIII has four more rules, and the Cairo file rarely survives it.

Saudi makers already appoint an SFDA-licensed authorized representative. The EU version of the role carries MDR Article 11(5) joint and several liability.

A MOHAP local agent is not an EU role and a free-zone licence is not a Union establishment. How UAE firms sit under MDR Articles 13, 14 and 16.

A SAHPRA establishment licence says who may trade, not whether a device conforms. What South African manufacturers must build for MDR, and what already counts.