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
| 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 Product (including Supplement) | 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 |
SFDA Variation Fee
| 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 a pre-pricing before submitting the registration application, the fee for this submission is SAR20,000. Regarding pricing appeals, the fee is SAR1,000.
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 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 |
Medical Device SFDA Fee
Medical Device Registration Fee (MDMA)
| 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, manuf. 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
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.