Prior to place medical devices on the market, any organization dealing with the importation and/or distribution shall apply for the Medical Device Establishment License (MDEL). The fees required varies (from USD 4000 to 9350) depending on type of medical devices they are dealing with.

License for Authorized Representative (AR)

The AR shall have separate licenses for each manufacturer it represents within the KSA. The fee required is fixed (around 1300 USD per year).

LICENSE VALIDITY:

MDMA certificate has a validity maximum 3 years. After July 1, 2021, the certificate will have a 3-years validity (consistently).

The validity of License for AR varies depending on the agreement between the manufacturer and the AR.

LICENSE TRANSFER:  License transfers are possible in Saudi Arabia.

AUTHORIZED REPRESENTATIVE/LICENSE HOLDER: Foreign manufacturer must appoint a company residing within the KSA to act on their behalf for specified tasks including dealing with the SFDA.

ADDITIONAL INFORMATION: After July 1, 2021, risk classification system and new marketing authorization request via GHTF route is no longer accepted.