SFDA Fees

This post outlines the fees charged by the Saudi Food and Drug Authority (SFDA) for product registration applications for drugs, biologicals, biosimilars, medical devices (MDMA), and other types of products.

We will also cover the inspection, license, and certificate fees for manufacturers, distributors, and warehouses, as well as the governmental costs and related charges applicable after the life cycle management approval, such as renewal, update, and variation fees.

We hope this post helps you accurately budget your regulatory project in Saudi Arabia.

Drug Fees

Registration

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

Type	SFDA Fees (SAR)	SFDA eSDR fee (SAR)
New Drugs (including Biologicals, Biosimilars, and Radiopharmaceuticals)	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	5000	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

Renewal

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

SFDA will invoice the following fees for drug variation applications for every SKU:

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

Clinical Trials

The fee is SAR 15,000 per application, payable by the sponsor or the assigned Contract Research Organisation (CRO). It is one of the requirements of SFDA clinical trials.

Pricing

SFDA allows companies to request pre-pricing before submitting the registration application; the fee for this submission is SAR 20,000. Regarding pricing appeals, the cost is SAR1,000 per registered SKU.

GMP Inspection

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

Product Certificates

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

Manufacturer Certificates

In addition to the GMP inspection fees, SFDA charges SAR 10,000 for every manufacturer certificate issued.

Scientific Office

A SAR 1,000/year fee is required when issuing the scientific office certificate.

Medical Device Fees

Registration

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

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	5,000
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

Update

Below is a list of MDMA Update fees due for SFDA according to update type:

Type of Change Request	SFDA Fees (SAR)
Add device/devices	5000
Add model / models	5000
Brand name change	5000
Change in device design	5000
Update label	1100
Update IFU	1100
Update advertising materials	1100
Renew DE	1500
Change jurisdiction	Full fees
Change classification	Full fees
Change the manufacturer’s address/name	Full fees
Minor change to the manufacturer’s name or address	5000
Change notified body	Full fees
Change Notified Body with a transition period letter	5000
Change notified body due to Brexit (Same NB different number)	5000

Authorised Representative

The fee for an authorised representative license is SAR 2,600 per year.

MDEL

Medical device establishment License MDEL fees depend on the types of devices the company deals with. They are SAR 5000, SAR 8000, or more.

Cosmetics Fees

There are no SFDA fees for cosmetics registration.

Food Fees

Food Application

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

Supplements Application

Applicants are required to pay SAR 5,000 per item during the food supplement registration. However, the SFDA classifies some supplements as health products in Saudi Arabia. For such products, please refer to the health product fees on this page.

Feed Application

Registration for animal feeds and fodder is free.

Classification Fee

The fee is SAR 1000 for each SFDA Classification application.

Read More:

SFDA Review Timelines