Regulatory Authority
Saudi Food and Drug Authority (SFDA)
Classification
I, II, III, IV
Medical Device Registration in Saudi Arabia
All Medical Devices are subject to registration.
A product to be registered in Saudi Arabia, firstly, must have already obtained the registration or a Marketing Authorization in Canada, Australia, USA, Japan or Europe. Furthermore, foreign manufacturers intending to market their Medical Devices in Saudi Arabia must appoint a Local Authorized Representative responsible for the registration process with the SFDA.
Applicant
Local Authorized Representative.
Timeframe and fees
5 months.
Validity
Class I: 3 years
All other classes already registered in Canada, Australia, Europe, Japan or USA: until the reference country registration expiry. If in these countries the registration does not expire, the Saudi Arabian registration goes for 3 years.
Labelling and documentation language
Medical Device documentation must be provided in English.
Professional use Medical Devices labelling must be provided in English, while home use Medical Devices labelling must be provided in Arabic.
Useful information
In order to register Medical Devices in Saudi Arabia, authorization in at least one of the following countries is required: USA, Canada, Europe, Japan or Australia. Furthermore, the approved labelling in one of the founding member countries of the Global Harmonization Task Force (GHTF) is recognized in Saudi Arabia.
