SFDA Fees: Details of all fees and amounts

sfda fees for registration

Here we list the Saudi Food and Drug Authority’s applicable fees for SFDA registration of products and the manufacturer’s GMP inspection fees. We will include the application fees for drug registration, medical device registration, and the cosmetics registration. Also, we are listing the governmental costs related to other life cycle management LCM submissions, such as renewal fees, updates, and the new SFDA variations fees.

In addition, we will try to simplify and combine all SFDA GMP fees into one table covering human and veterinary drug manufacturer inspection fees. Then, we will provide a detailed list of sfda medical device fees for MDNR, MDMA, and the authorized representative (AR) applications. Gathering the applicable costs should be helpful for those responsible for the regulatory budget.

Drug SFDA Fee

Drug Registration Fee

TypeSFDA Fees (SAR)SFDA eSDR fee (SAR)
New Drug (including Biosimilars)9500020000
Additional Dosage Form9500019000
Additional Strength240003600
Additional Pack Type50002400
Additional Pack Size1000150
Generic Drug400008000
Additional Dosage Form400008000
Additional Strength100001500
Additional Pack Type5000500
Additional Pack Size1000150
Health or Herbal Product (including Supplement)200004000
Additional Dosage Form200004000
Additional Strength500750
Additional Pack Type2000200
Additional Pack Size1000150
Veterinary Drug50001000
Additional Dosage Form5000300
Additional Strength1000150
Additional Pack Type1000150
Additional Pack Size1000150
IV Fluids150003000
Additional Dosage Form15000
Additional Strength1000150
Additional Pack Type1000100
Additional Pack Size1000150

Drug Renewal Fee

TypeSFDA Fees (SAR)SFDA eSDR fee (SAR)
New Drug Renewal300003000
Generic Drug Renewal100001000
Health & Herbal Renewal8000800
Veterinary Drug Renewal1000100
IV Fluids Renewal5000500

SFDA Variation Fee

TypeSFDA Fees (SAR)SFDA eSDR fee (SAR)
Drug Variation30001000

Clinical Trials Fees

It is SAR15,000 per application paid by the sponsor or the assigned CRO. It is one of the SFDA clinical trials requirements.

Drug Manufacturer Inspection Fee (GMP)

The following are the inspection fees for the registration and inspection of a manufacturer. Note that the inspection fees are applicable in every site registration renewal (5 Years).

Country or Region of ManufacturerSFDA Fee (Human)SFDA Fee (Veterinary)
Saudi Arabia330009000
GCC, Yemen, Iraq, Jordan, Syria, Lebanon, Egypt6100026000
Libya, Algeria, Tunisia, Morocco8800035200
Africa8800040000
Europe, Turkey12100056800
Southeast Asia (Malaysia, Singapore, India, Pakistan, Iran, Thailand, Philippines)8000041600
North and South America161000112000
Middle Asia (China, Korea)10300054000
Japan, Russia14700058800
Australia, New Zealand 18400073600

Medical Device SFDA Fee

Medical Device Registration Fee (MDMA)

Application (Device Class)SFDA Fees (SAR)
Class I low risk medical device (MDNR) – Non MDMA500
All Class I/ General IVD(Other)/ Exempt IVD(TGA)  15,000
All Class II/ Class IIa /Self-test IVD, Listable IVD19,000
Class IIb /Class III (CA, PAL) /Annex II List B (IVD)21,000
All other Class III/ Class IV /AIMD /Annex II List A (IVD)/ Registrable IVD23,000
MDMA Renewal Only    (New Product cannot be added in the renewal process)EU 5,000 US 1,100
Update-Major (adding product, Models, Brand Name Change, manuf. address change, change in device design (All Jurisdictions)5,000
Minor update for Label, IFUs, and advertising material1,100
Renew Update Design Examination Certificate (EU Jurisdiction)1,500 per DE Renew

Authorized Representative AR

It is an annual fee of SAR 2600. If the AR is 5 years contract, then the amount is to be paid in advance for the whole period.

MDEL

Medical device establishment License MDEL fees depend on the types of devices dealt with in the company. It is SAR 5000, or SAR 8000, or more.

Cosmetics SFDA Fee

There are no applicable SFDA cosmetics registration fees.

Food

Food Registration Fee

  • There are no food registration fees on usual/ordinary food products.
  • Advanced food (With vitamins or special formulas): SAR 5000/product application

Feed Registration Fee

Animal feeds and fodders registration are at no cost.

Food Supplements Fee

If it is in the form of food such as candy and gummies, the cost is SAR5000/item. However, supplements in a pharmaceutical form are considered health products. Refer to the above on this page for health products fees.

Classification Fee

It is SAR1000 for every SFDA Classification application.

Our website uses cookies and asks for your insensitive personal data to enhance your browsing experience.