According to MDR and IVDR requirements, non-EU countries must appoint a compliant authorized representative (EU representative) within an EU member state. The EU representative is responsible for assisting non-EU companies in responding to regulatory requirements, submitting relevant regulatory documents, and completing product registration. Simultaneously, the EU representative is responsible for after-sales issues related to the company's products in EU countries, assisting with post-market surveillance, and collecting data on marketed products.

The FDA requires non-US companies to appoint a US authorized representative before applying for registration in the US. The US authorized representative is responsible for communicating with the FDA and providing timely feedback.

Eustar Medical provides services such as European and US authorized representative services. For inquiries and cooperation, please contact info@eu-star.email.