Medical Device Registration and Approval in Saudi Arabia

General country-specific regulatory information is provided on this page for medical device registration and approval in Saudi Arabia. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Saudi Arabia, to expedite the preparation of your medical device or IVD registration application.

Medical Device Regulations and Classification in Saudi Arabia

REGULATORY AUTHORITY: Saudi Food and Drug Authority (SFDA)

CLASSIFICATION SYSTEM: 

The devices will be classified according to the regulations that apply in one or more of the GHTF Founding Member jurisdictions (namely Australia, Canada, Japan, USA, or the EU).

  • EU – I/IIa/IIb/III (MD); General IVD/Self-test/Annex I/Annex II (IVD)
  • Australia – I/Is/Im/IIa/IIb/III/AIMD (MD); 1/2/3/4 (IVD)
  • USA – I/II/III (MD & IVD)
  • Japan & Canada – I/II/III/IV (MD & IVD)

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.  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.

Last updated on November 16, 2020.


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