EU Authorized Representative (EAR) Role, Responsibilities & Appointment Process
Appointing an EU Authorized Representative is the most important step for IVD or medical device manufacturers established outside the European
Appointing an EU Authorized Representative is the most important step for IVD or medical device manufacturers established outside the European
Germany has implemented Regulation (EU) 2019/6 on veterinary medicines. Companies entering the market need to comply with these standards. Being
Japan has a well-defined framework for veterinary medicines. For global regulatory teams and animal health companies, however, meeting the requirements
Cosmetic regulations in Canada are laid out under the Food & Drugs Act and the Cosmetic Regulations by Health Canada.
Before entering the Mexican market, medical devices need Registro Sanitario, or Sanitary Registration. Recently, regulatory simplification and a broader abbreviated
Product registration is not enough to introduce a veterinary pharmaceutical into the Indian market. Before commercialisation, companies need to meet
A separate UK compliance process now needs to be undertaken to sell cosmetics in Great Britain. Brands that only notify
In Japan, cosmetics have to meet the requirements and standards before they can be brought into the market. It is
For veterinary pharmaceuticals to be sold in the U.S. market, they must be approved by the FDA Center for Veterinary