According to MDR and IVDR requirements, non-EU countries need to designate compliant authorized representatives (European representatives) in EU member states. Odai needs to assist companies in non-EU countries to respond to the requirements of regulatory authorities, assist companies in submitting relevant regulatory documents, and complete product registration and filing. At the same time, Ou Dai needs to be responsible for the after-sales issues of the company's products in EU countries, assist the company in conducting post-market supervision of products, and collect data on marketed products.

The FDA requires non-U.S. companies to designate a U.S. authorized representative before applying for registration in the United States. The U.S. authorized representative must assist the company in communicating with the FDA and provide information back to the company in a timely manner.

Eu-star Medical provides European authorized representatives, American authorized representatives and other services. Welcome to consult and cooperate. Contact email: info@eu-star.email.