Oversea manufacturer is required to appoint an authorized agent for the application of registration of the imported medical devices and IVD products. Starting from November 2019, all authorized agents in China needs to own a Certificate Authority for the purpose of electronic document submission. OSMUNDA Group holds the CA and can act as your legal agent, as well as your regulatory consultant.

Similarly, an EAR serves as a legal entity designated by non-European Union (EU) manufacturers, to represent them in the EU and ensure their compliance with the European Directives.