EU Importer

Introduction to the "EU Importer" service

In accordance with the general obligations of the EU 2017/745 Regulations Article 13 of the importers, non-EU enterprises' products exported the EU can only put products into the EU market through the EU importers. In order to put the product into the market, the responsibility and obligations of the EU importer are as follows:

1. Importers should help enterprises provide customs clearance and provide goods storage warehouses without damage product safety and performance requirements;
2. The importer is responsible for reviewing the product packaging. Its names, registered business names or registered trademarks on the equipment or its packaging or with the attached documents, and the address of its business registration and the access to the importer;
3. Importers should preserve unqualified devices and recalls and withdrawal complaints, and provide all information as required by manufacturers, authorized representatives and dealers;
4. The importer is responsible for handling complaints and reports from related suspicious events from medical professionals, patients and users, and on the relevant suspicious incidents of marketing equipment;
5. Importers should cooperate with the competent institution to take any actions to reduce the risk caused by their placement in market equipment according to the latter requirements. Importers should provide free device samples according to the requirements of the competent authority of member states.

If you have no EU importers or want to change the EU importer, please contact us at any time.