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SFDA Fees: Drug, Medical Device, and Food Applications

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The Author

Regulatory Editor

Here, we list the Saudi Food and Drug Authority’s (SFDA) fees for product registration and other applicable fees, such as manufacturer’s GMP inspection and establishment licenses. We will include the application fees for drug registration, medical device registration, and cosmetics registration. Also, we are listing the governmental costs related to other life cycle management LCM submissions, such as renewal fees, updates, and the 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 here should be helpful for those responsible for the regulatory budget.

Drug SFDA Fee

Drug Registration Fee

The following fees are invoiced after submission of the eSDR application for drug registration, it does not include the 15% VAT:

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 Products200004000
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

Variation Fee

The following fees for drug variation application will be invoiced by SFDA for every SKU:

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 Pricing Fees

SFDA allows companies to request pre-pricing before submitting the registration application; the fee for this submission is SAR20,000. Regarding pricing appeals, the cost is SAR1,000 per registered SKU.

Drug Manufacturer Inspection Fee (GMP)

The following are the inspection fees for drug manufacturer GMP licenses. Note that the inspection fees are applicable on new site registration or renewal every 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

Drug Certificates Fee

Every time a drug SFDA certificate is issued, a fee of SAR 1,000 is collected by SFDA.

Manufacturer Registration

Separate from the GMP fees, SFDA charges SAR 10,000 for every manufacturer license issued.

Scientific Office License Fees

When issuing the scientific office license, a fee of SAR1000/year.

Medical Device SFDA Fee

Medical Device Registration Fee (MDMA)

After submission of an MDMA registration application, update, or renewal, the SFDA will issue the related applicable fee as below:

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, manufacturer 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

The annual fee for a new or renewed authorised representative license is SAR 2600. If the AR license is requested for multiple years, the combined fees must be paid in advance.

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 SFDA cosmetics registration fees.

Food

Food Registration Fee

  • There are no food registration fees for simple food products.
  • Special food registration (With vitamins or special formulas): SAR 5000/product application

Food Supplements Fee

If the supplement is in the form of food, such as candy and gummies, the cost is SAR5000/item, it is also called special food registration. However, supplements in pharmaceutical form are considered health products. Refer to health product fees for their related fees on this page.

Feed Registration Fee

Animal feeds and fodders registration are at no cost.

Classification Fee

It is SAR1000 for every SFDA Classification application.

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The Author

Regulatory Editor

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