Medical Devices are subject to registration.
A Local Representative (Registrant) must be appointed and he will be responsible for the registration process with the competent Authority. Furthermore, device samples shall be submitted for on-site testing.
Once the registration process is complete, the importer shall obtain a permit for registered devices import.
Foreign manufacturer via local representative (Registrant).
Timeframe and fees
Registration fees: $ 900 – 2.400
Registration timeframe: 3 – 12 months
Labelling and documentation language
Documentation and labelling should be provided in English.
Following registration, all devices are subject to post-market surveillance. Safety, quality and performance are continuously monitored.