Regulatory Authority

Saudi Food and Drug Authority (SFDA)


Classification

I, II, III, IV


Procedure

All medical devices are subject to registration.

A product to be registered in Saudi Arabia, first of all, 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.


Labeling and documentation language

Medical device documentation must be provided in English.
Professional use medical devices labeling must be provided in English, while home use medical devices labeling 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 labeling in one of the founding member countries of the Global Harmonization Task Force (GHTF) is recognized in Saudi Arabia.