欧盟市场商机拓展

1. Become your importer

Problems encountered by manufacturers:

MDR/IVDR has many responsibilities that existing European customers are not willing to take on

MDR/IVDR responsibilities that existing European customers are not able to undertake, such as quality systems, Eudamed registration, regulatory audits

Multiple importers need to prepare a variety of importer labels, which is not conducive to manufacturers to prepare goods. Some countries require the importer's information to be affixed to the product, not just the outer packaging.

European customers are not willing to display other non-neutral importer contact information on their products. (There may be some competition, and the end customer will contact the importer on the label directly)

What are the importer's responsibilities and obligations for?

Does the importer have to actually purchase the manufacturer's products? No. MDR/IVDR has no requirement.

What is the difference between an Importer, an importer and a Distributor

Importers bring products from China into the EU, and distributors sell EU products to end customers.

As long as the manufacturer registers the products according to the process and requirements, we assume the responsibilities and obligations of the importer.

2. Create integrated Amazon store and customer service for partners

Why do EU cross-border e-commerce need an EU authorized representative?

According to EU law, in order to achieve product traceability, products with CE marking placed on the EU market by the manufacturer must be marked with the manufacturer's name and contact address, if the manufacturer is from a country outside the European Economic Area EEA (including EU and EFTA). Its products must bear both the name and contact address of the manufacturer and the manufacturer's EU authorised representative on the label (nameplate or package).

In order to ensure that the competent authorities of the European Union can timely check the technical document (TCF) of the product affixed with the CE mark, foreign manufacturers should keep the latest version of the technical document in the authorized representative office of the European Union, the storage time is 10 years after the last batch of products exported.

Any failure/accident/recall of products of manufacturers outside the EU in the EU shall be contacted by the EU agent, notified and communicated with the competent authorities.