SFDA Fees: Drug, Medical Device, and Food Applications

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:

Type	SFDA Fees (SAR)	SFDA eSDR fee (SAR)
New Drug (including Biosimilars)	95000	20000
Additional Dosage Form	95000	19000
Additional Strength	24000	3600
Additional Pack Type	5000	2400
Additional Pack Size	1000	150
Generic Drug	40000	8000
Additional Dosage Form	40000	8000
Additional Strength	10000	1500
Additional Pack Type	5000	500
Additional Pack Size	1000	150
Health or Herbal Products	20000	4000
Additional Dosage Form	20000	4000
Additional Strength	500	750
Additional Pack Type	2000	200
Additional Pack Size	1000	150
Veterinary Drug	5000	1000
Additional Dosage Form	5000	300
Additional Strength	1000	150
Additional Pack Type	1000	150
Additional Pack Size	1000	150
IV Fluids	15000	3000
Additional Dosage Form	15000	–
Additional Strength	1000	150
Additional Pack Type	1000	100
Additional Pack Size	1000	150

Drug Renewal Fee

Type	SFDA Fees (SAR)	SFDA eSDR fee (SAR)
New Drug Renewal	30000	3000
Generic Drug Renewal	10000	1000
Health & Herbal Renewal	8000	800
Veterinary Drug Renewal	1000	100
IV Fluids Renewal	5000	500

Variation Fee

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

Type	SFDA Fees (SAR)	SFDA eSDR fee (SAR)
Drug Variation	3000	1000

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 Manufacturer	SFDA Fee (Human)	SFDA Fee (Veterinary)
Saudi Arabia	33000	9000
GCC, Yemen, Iraq, Jordan, Syria, Lebanon, Egypt	61000	26000
Libya, Algeria, Tunisia, Morocco	88000	35200
Africa	88000	40000
Europe, Turkey	121000	56800
Southeast Asia (Malaysia, Singapore, India, Pakistan, Iran, Thailand, Philippines)	80000	41600
North and South America	161000	112000
Middle Asia (China, Korea)	103000	54000
Japan, Russia	147000	58800
Australia, New Zealand	184000	73600

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 MDMA	500
All Class I/ General IVD(Other)/ Exempt IVD(TGA)	15,000
All Class II/ Class IIa /Self-test IVD, Listable IVD	19,000
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 IVD	23,000
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 material	1,100
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.