REGULATORY AUTHORITY: Saudi Food and Drug Authority (SFDA)
CLASSIFICATION SYSTEM:
After July 1, 2021, both medical devices and IVDs will follow this risk classification system:
- Class A
- Class B
- Class C
- Class D
TIMEFRAME:
Official Timeline
Medical Device Marketing Authorization (MDMA): 35 working days
Medical Device Listing in Medical Device National Registry (MDNR) – 4 working days (Class A); 10 working days (for Class B, C, D)
Actual Timeline – (based on experience)
Medical Device Marketing Authorization (MDMA): up to 2 months
Medical Device Listing in Medical Device National Registry (MDNR): up to 2 weeks
SPECIAL REQUIREMENTS:
Local testing is required for devices that are listed in Annex 1 of MDS G29. In most cases, however, the application is waived from local testing.
LOCAL FEES (New Application):
Medical Device Marketing Authorization (MDMA):
Class I/General IVDs/Exempt IVD (TGA) – USD 4000
Class II/IIa/Self-test IVD/Listable IVD – USD 5067
Class IIb/Class III (CA, PAL)/Annex II List B (IVD) – USD 5600
Class III/Class IV/AIMD/Annex II List A (IVD)/Registrable IVD – USD 6133
Medical Device Listing in Medical Device National Registry (MDNR): USD 135
*Please note that these are fees currently enforced. However, as soon as the new regulation is enforced in January 2021, the new fee schedule will be implemented.
LOCAL FEES (Manufacturer):
Establishment License
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.
