Global Product Registration for Medical Devices

Lexium is having experienced partners in various countries which can help your company to access the growing global medical devices market. Our expert team will do a conformity assessment for various device types.

  • Assess the local regulatory body and the registration requirements for your device.
  • Review of the technical file to ensure compliance.
  • Assistance with compilation or review of clinical survey.
  • Application submission and handling of queries.
  • Post market obligations
  • Authorised representative service for specific country.

At present we are offering our services for the medical device registration in the following countries .

Country Regulatory Body
Australia TGA
South Africa SAHPRA
Brazil ANVISA
UK MHRA
UAE DCD MOH
Saudi Arabia SFDA
Indonesia MOH
Thailand MDCD
Ethiopia FMHACA
Kenya PPB
Algeria NAFDAC

Please get in touch with us for your product registration requirements.