EU Authorized Representative by Manufacturer Country
From FDA Clearance to CE Marking: EU Authorized Representative for United States Manufacturers
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.
EU Authorized Representative for Chinese Medical Device Manufacturers: From NMPA to MDR
An NMPA registration certificate carries no weight under MDR. How Chinese exporters fix classification, Class I self-declaration and legal-manufacturer risk.
EU Authorized Representative for India: From the Medical Devices Rules 2017 to MDR 2017/745
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.
EU Authorized Representative for Korean Medical Device and IVD Manufacturers
MFDS notification, certification and approval stop at Korea's border. How Korean dental, aesthetic and IVD exporters classify and certify under MDR and IVDR.
EU Authorized Representative for Taiwanese Medical Device and Component Manufacturers
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.
Inside the Customs Union, Outside the Union: EU Authorized Representative and Türkiye
TİTCK applies MDR word for word under the Tıbbi Cihaz Yönetmeliği, and the EU-Türkiye Customs Union decides where your EU Authorized Representative may sit.
AMAR Registration and MDR: EU Authorized Representative for Israeli Manufacturers
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.
EU Authorized Representative for Brazil: RDC 751/2022, B-GMP and the Annex IX Gap
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.
EU Authorized Representative for UK Manufacturers: Great Britain, Northern Ireland, EU
MHRA regulates Great Britain under UK MDR 2002 while EU MDR applies in Northern Ireland. EU Authorized Representative support for British device makers.
MDSAP to MDR: EU Authorized Representative for Canadian Medical Device Manufacturers
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.
ARTG to MDR: EU Authorized Representative for Australian Medical Device Manufacturers
TGA Essential Principles resemble MDR GSPRs but are separate law, and MDSAP stops at the EU border. EU Authorized Representative for Australian manufacturers.
From WAND Notification to MDR: EU Authorized Representative for New Zealand 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.
EU Authorized Representative for Singapore: Reliance Runs Only One Way
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.
EU Authorized Representative for Malaysia: Where Examination and Surgical Gloves Part Company
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.
EU Authorized Representative for Vietnam: Product Owner and Manufacturer of Record
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.
EU Authorized Representative for Thailand: Latex, Rubber-Derived Devices and Thai FDA Tiers
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.
EU Authorized Representative for Indonesia: AKL, AKD and Who Holds What in Europe
Kemenkes izin edar puts an AKL registration in your distributor's hands. MDR keeps every obligation with the manufacturer. EU Authorized Representative service.
EU Authorized Representative for Pakistan: Sialkot Instruments and MDR Class Ir
Sialkot's reusable surgical instruments are MDR class Ir, so a notified body assesses reprocessing. DRAP enlistment does not. EU Authorized Representative.
EU Authorized Representative for Bangladesh: Dressings, Gowns and the Rule 4 Problem
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.
EU Authorized Representative for Mexico: Contract Manufacturers and Own-Brand Device Exporters
COFEPRIS registro sanitario and its equivalence routes produce no EU declaration of conformity. EU Authorized Representative for Mexican device exporters.
EU Authorized Representative for Egypt: From an EDA Licence to MDR Annex II
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.
EU Authorized Representative for Saudi Arabia: The Same Title, A Different Liability
Saudi makers already appoint an SFDA-licensed authorized representative. The EU version of the role carries MDR Article 11(5) joint and several liability.
EU Authorized Representative for South Africa: Establishment Licence to CE Marking
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.
