Saudi Food and Drug Authority ( SFDA )
Overview
SFDA
SFDA protects Saudi society through legislation and an effective regulatory system, supervising more than ten vital sectors that touch every business owner in the health, food, and industrial sectors. Direct engagement with SFDA requires deep understanding of regulations, proficiency in operating its multiple electronic systems (GHAD System, FASEH System, RSD Drug Tracking, SDR eSDR System, Portables Platform, E-cosma Cosmetics Listing System), plus precise knowledge of fee payment mechanisms through the SADAD payment system (Biller Number 109) — and awareness of the differences between the multiple billing systems (Drug Sector Billing, Operations Sector Billing for medical devices, the Unified Fee System). Motaded Limited delivers an end-to-end service: we handle registration, documentation, and follow-up on your behalf; ensure your file is inspection-ready; accelerate clearance of imported shipments; track your requests in the Transactions Inquiry Center (MCS) and the Nnjzha service; and renew licenses before expiry.
Billing and Payment Systems
SADAD Payment System — SFDA Biller Number:
109
Electronic Invoice Issuance Systems (multiple):
1. Unified SFDA Service Fee System
Description: The unified system for service invoice issuance
2. Drug Sector Billing and Payment System
Description: Specific to the drug and pharmaceutical preparations sector
3. Operations Sector Billing and Payment System
Description: Specific to medical devices and products sector
4. GHAD System
Description: Specific to animal feed and pesticides
1. Establishment License Fees (19 license types)
Source: SFDA Establishment Licensing Services Guide (Official PDF)
# | License Type | Fee (SAR) | Duration |
1 | Consulting Office License | 1,000 SAR per activity | 5 years |
2 | Private Laboratory License | 5,000 SAR | 5 years |
3 | Private Lab Designation | 1,000 SAR per activity | 3 years |
4 | Conformity Assessment Body Designation | Varies by sector, activity, and country | 3 years |
5 | Scientific Office License | 1,000 SAR | 5 years |
6 | Pharmaceutical Manufacturing Plant License | 10,000 SAR | 5 years |
7 | Pharmaceutical Warehouse License | 4,000 SAR | 5 years |
8 | Clinical Studies Center License | 5,000 SAR | 5 years |
9 | Cosmetics Manufacturing Plant License | 5,000 SAR | 5 years |
10 | Cosmetics Warehouse License | 3,000 SAR | 5 years |
11 | Food Manufacturing Plant License | Calculated by factory category and license duration | Varies |
12 | Food Warehouse / Distribution Center License | By area and duration (60-120 halalas per m² + 1,000) | 1 to 3 years |
13 | Animal Feed Manufacturing Plant License | No fees currently | Varies |
14 | Animal Feed Warehouse License | No fees currently | Varies |
15 | Local Medical Devices Manufacturing Plant License | 5,000 SAR | 5 years |
16 | Medical Devices Warehouse License | 4,000 SAR | 5 years |
17 | Medical Devices Authorized Representative (AR) License | 2,600 SAR per year | 1 to 10 years |
18 | Medical Devices Import & Distribution License | Class A: 25,000 | B: 15,000 | C: 8,000 | D: 5,000 SAR | 1 year |
19 | Optics License for Medical Devices Establishments | Class A: 25,000 | B: 15,000 | C: 8,000 SAR | 1 year |
2. Drug Registration Fees (25 items)
Note: Fees exclude VAT 15%. Composed of SFDA fees + SDR eSDR system fees.
# | Registration Type | SFDA Fee | SDR Fee | Total |
1 | New drug registration (chemical/biological/biosimilar/radioactive) | 95,000 | 20,000 | 115,000 |
2 | New drug — pharmaceutical form | 95,000 | 19,000 | 114,000 |
3 | New drug — additional strength | 24,000 | 3,600 | 27,600 |
4 | New drug — additional pack type | 5,000 | 2,400 | 7,400 |
5 | New drug — additional pack size | 1,000 | 150 | 1,150 |
6 | Generic drug registration | 40,000 | 8,000 | 48,000 |
7 | Generic drug — pharmaceutical form | 40,000 | 8,000 | 48,000 |
8 | Generic drug — additional strength | 10,000 | 1,500 | 11,500 |
9 | Generic drug — additional pack type | 5,000 | 500 | 5,500 |
10 | Generic drug — additional pack size | 1,000 | 150 | 1,150 |
11 | Health or herbal product registration | 20,000 | 4,000 | 24,000 |
12 | Health/herbal — pharmaceutical form | 20,000 | 4,000 | 24,000 |
13 | Health/herbal — additional strength | 5,000 | 750 | 5,750 |
14 | Health/herbal — additional pack type | 2,000 | 200 | 2,200 |
15 | Health/herbal — additional pack size | 1,000 | 150 | 1,150 |
16 | Veterinary drug registration | 5,000 | 1,000 | 6,000 |
17 | Veterinary — pharmaceutical form | 5,000 | 300 | 5,300 |
18 | Veterinary — additional strength | 1,000 | 150 | 1,150 |
19 | Veterinary — additional pack type | 1,000 | 150 | 1,150 |
20 | Veterinary — additional pack size | 1,000 | 150 | 1,150 |
21 | Intravenous solutions registration | 15,000 | 3,000 | 18,000 |
22 | IV solutions — pharmaceutical form | 15,000 | - | 15,000 |
23 | IV solutions — additional strength | 1,000 | 150 | 1,150 |
24 | IV solutions — additional pack type | 1,000 | 100 | 1,100 |
25 | IV solutions — additional pack size | 1,000 | 150 | 1,150 |
3. Drug Registration Renewal Fees (5 items)
# | Renewal Type | SFDA Fee | SDR Fee | Total |
1 | New drugs renewal | 30,000 | 3,000 | 33,000 |
2 | Generic drugs renewal | 10,000 | 1,000 | 11,000 |
3 | Health or herbal product renewal | 8,000 | 800 | 8,800 |
4 | Veterinary drugs renewal | 1,000 | 100 | 1,100 |
5 | Intravenous solutions renewal | 5,000 | 500 | 5,500 |
4. Drug Registration Variation Fees
# | Change Type | SFDA Fee | SDR Fee | Total |
1 | Drug registration variation/change | 3,000 | 1,000 | 4,000 |
5. Clinical Trials and Pricing Fees
# | Request Type | Fee (SAR) |
1 | Clinical trial license application | 15,000 SAR |
2 | Pre-pricing request before registration submission | 20,000 SAR |
3 | Pricing objection per registered product | 1,000 SAR |
6. Drug Certificate Fees
# | Certificate Type | Fee (SAR) |
1 | Drug certificate (per certificate) | 1,000 SAR |
2 | Manufacturer certificate (per certificate) | 10,000 SAR |
3 | Scientific Office certificate (annually) | 1,000 SAR |
7. Good Manufacturing Practice (GMP) Inspection Fees by Country
Required upon new manufacturing site registration and renewal every five years. Fees vary substantially by country.
# | Country or Region | Human Drugs | Veterinary Drugs |
1 | Saudi Arabia | 33,000 | 9,000 |
2 | GCC, Yemen, Iraq, Jordan, Syria, Lebanon, Egypt | 61,000 | 26,000 |
3 | Libya, Algeria, Tunisia, Morocco | 88,000 | 35,200 |
4 | Africa | 88,000 | 40,000 |
5 | Europe and Turkey | 121,000 | 56,800 |
6 | Southeast Asia (Malaysia, Singapore, India, Pakistan, Iran, Thailand, Philippines) | 80,000 | 41,600 |
7 | North & South America | 161,000 | 112,000 |
8 | Central Asia (China and Korea) | 103,000 | 54,000 |
9 | Japan and Russia | 147,000 | 58,800 |
10 | Australia and New Zealand | 184,000 | 73,600 |
8. Medical Devices Registration Fees
# | Device Class | Fee (SAR) |
1 | All Class I / General IVD (other) / IVD exempt (TGA) | 15,000 SAR |
2 | All Class II / IIa / Self-test IVD / Listable IVD | 19,000 SAR |
3 | Class IIb / Class III (CA, PAL) / Annex II List B (IVD) | 21,000 SAR |
4 | All other Class III/IV / AIMD / Annex II List A (IVD) / Registerable IVD | 23,000 SAR |
5 | MDMA renewal only | 5,000 SAR |
6 | Major update (adding product, models, brand name change, manufacturer address change, device design change) | 5,000 SAR |
7 | Minor update (labels, instructions for use, promotional materials) | 1,100 SAR |
9. Cosmetics, Food, Feed, and Classification Fees
# | Service Type | Fee (SAR) |
1 | Cosmetic product registration in E-cosma electronic system | No fees |
2 | Simple food product registration | No fees |
3 | Special foods registration (per product) | 5,000 SAR |
4 | Dietary supplements registration (per product) | 5,000 SAR |
5 | Animal feed product registration | No fees |
6 | Product classification by SFDA (per request) | 1,000 SAR |
Key services
SFDA Registration
• SFDA Establishment Registration: We master all 19 license types — consulting offices, private laboratories, scientific offices, manufacturing plants and warehouses for drugs, food, cosmetics, medical devices, and animal feed.
Clearance Services
• Clearance Services through the FASEH platform (faseh.sfda.gov.sa): Preparing imported shipment files, accelerating regulatory approvals, and ensuring product compliance with Saudi regulations and Gulf specifications.
Medical Devices Registration
• Medical Devices Registration and Licensing: Establishment registration, product licensing across its four classes (A, B, C, D), GMP certificate issuance, and Authorized Representative appointment at SAR 2,600/year.
Cosmetic Product Registration
• Cosmetic Product Registration in the E-cosma electronic listing system: Preparing the technical product file, official translation, and SFDA liaison through to final approval. (SFDA charges no fees for cosmetic product registration.)
Pharmaceutical and Drug Product Registration
• Pharmaceutical and Drug Product Registration in the SDR eSDR system: Manufacturing site registration, product registration (SAR 95,000 for new drugs), drug pricing, RSD drug tracking enrollment, and periodic license renewal.
Saudi Halal Certificates
• Halal Certificates through the Saudi Halal Center (halal.gov.sa): Preparing the establishment for Saudi halal standards, coordinating with accredited inspection bodies, certificate issuance, and renewal.
Animal Feed and Facility Registration
• Animal Feed and Facility Registration: Registering plants and warehouses in the National Feed Register (currently no fees), product registration, and compliance with the Saudi Feed Regulation.
Nnjzha Service and MCS
• Nnjzha Service and MCS: Following up on pending requests, tracking transactions in the inquiry system (mcs.sfda.gov.sa), and resolving issues with SFDA through the "Nnjzha" platform.
Regulatory Compliance Advisory
• Regulatory Compliance Advisory: Reviewing your establishment's readiness for regulatory inspection, training staff on SFDA requirements, and preparing license files for renewal.
How it works
- Activity assessment
• Step 1: Activity assessment and requirement scoping — Identify the target sector (food/drug/medical device/cosmetics/etc.) and SFDA's specific requirements for your establishment category among the 19 license types.
- Electronic registration
• Step 2: Electronic registration — Register in the sector-specific electronic system: GHAD System for feed and pesticides, Medical Devices Registration System, SDR eSDR for drugs, E-cosma for cosmetics.
- Technical file preparation
• Step 3: Technical file preparation — Commercial Registration with the correct economic activities accepted by SFDA, other authority licenses (Ministry of Commerce, Municipality, Industry, Civil Defense), site layouts, quality procedures, and GMP/ISO 13485:2016 certificates where required.
- Fee invoice issuance
• Step 4: Fee invoice issuance — From the appropriate electronic system (Drug Sector dsis.sfda.gov.sa, Operations Sector for medical devices, the Unified Fee System).
- Fee payment — Through the SADAD
• Step 5: Fee payment — Through the SADAD payment system using Biller Number 109 dedicated to the Saudi Food and Drug Authority. Note that SFDA fees vary substantially by service type (from SAR 0 for cosmetic products to SAR 184,000 for international GMP inspection).
- On-site inspection
• Step 6: On-site inspection — Scheduling SFDA inspection of the establishment site to verify actual compliance with the standards declared in the technical file.
- License or registration certificate issuance
• Step 7: License or registration certificate issuance — After passing inspection, SFDA issues a license for a specific period (1 year for import licenses, up to 5 years for factories, up to 10 years for Authorized Representative).
- Operational system registration
• Step 8: Operational system registration — RSD drug tracking, eSDR electronic reporting, Portables platform where applicable.
- Periodic renewal follow-up
• Step 9: Periodic renewal follow-up — Tracking license expiry dates, paying renewal fees before expiration (note new drug renewal is SAR 33,000).
- Periodic reporting
• Step 10: Periodic reporting — Drug error reports, adverse event reports, recall and withdrawal reports as required by sector.
When you need this platform
sectors
• Saudi Arabia's sole regulator for over 10 sectors: food, drugs, medical devices, laboratories, cosmetics, halal, nutrition, animal feed, pesticides, tobacco.
register with SFDA
• Every establishment operating in these sectors within Saudi Arabia is mandated to register with SFDA before commencing commercial activity — 19 different license types.
clearance
• Every imported product in these sectors requires clearance through the FASEH platform (faseh.sfda.gov.sa) before entering the market.
compliance results
• Non-compliance results in activity suspension, shipment confiscation, financial penalties, and license cancellation.
SFDA registration
• SFDA registration unlocks export pathways to GCC and global markets through international regulator acceptance of Saudi certificates.
Halal certification
• Halal certification from the Saudi Halal Center is internationally recognized and adds competitive value for products in Islamic markets.
drug tracking system
• The RSD drug tracking system (rsd.sfda.gov.sa) is mandatory for every drug warehouse and pharmacy in Saudi Arabia.
Electronic drug dossier
• Electronic drug dossier (eSDR) and electronic reporting are mandatory for every local or importing pharmaceutical company.
New drug registration
• New drug registration fees can reach SAR 115,000 (SAR 95,000 SFDA + SAR 20,000 SDR system), and GMP inspection fees can reach SAR 184,000 (for manufacturers in Australia and New Zealand).
SFDA fees
• Value Added Tax (VAT) 15% is added on top of all SFDA fees.
Requirements
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• Valid Commercial Registration containing the activity from SFDA's accepted economic activities list, issued from the same administrative region as the establishment site.
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• Valid municipal license or permit from the government authority concerned with site licensing.
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• Civil Defense license or permit from the government authority concerned with safety regulations (for warehouses and factories).
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• MISA Investment License from the Ministry of Investment (for companies with foreign or mixed capital).
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• Industrial license from the Ministry of Industry and Mineral Resources (for manufacturing plants).
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• Lease contract or property deed for the establishment site.
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• Saudi manager holding at least a Bachelor's degree (for most licenses).
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• Qualified Saudi technical officer specialized for each activity, holding at least a Bachelor's degree per the guidance manual for each license type.
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• Qualified Saudi quality manager (for manufacturing plants).
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• Accreditation certificate from the Saudi Accreditation Center or a body holding ILAC/IAF membership (for laboratories and conformity assessment bodies).
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• Quality management systems: ISO 13485:2016 for medical devices, ISO 9001 and HACCP for food.
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• Plan to localize technical positions within 3 years (50% maximum) for laboratories and conformity assessment bodies.
Frequently asked questions
Question 1: What is SFDA's biller number in the SADAD payment system?
Answer: The Saudi Food and Drug Authority's biller number in the SADAD payment system is 109. This number is used to pay all SFDA service fees, but invoice issuance occurs through four different electronic systems by sector: the Unified Service Fee System, the Drug Sector System (dsis.sfda.gov.sa), the Operations Sector System for medical devices, and the GHAD System for feed and pesticides.
Question 2: How much does it cost to register a new drug with SFDA?
Answer: New drug registration (chemical/biological/biosimilar/radioactive) costs a total of SAR 115,000 (SAR 95,000 SFDA fees + SAR 20,000 SDR eSDR system fees), excluding VAT 15%. Generic drugs total SAR 48,000 (40,000 + 8,000). Health or herbal products SAR 24,000 (20,000 + 4,000). Veterinary drugs SAR 6,000 (5,000 + 1,000).
Question 3: How much does it cost to license a medical device establishment with SFDA?
Answer: Fees vary by license type: Local manufacturing plant license or cosmetics manufacturing plant license is SAR 5,000 for 5 years, medical devices warehouse is SAR 4,000 for 5 years, medical devices import and distribution license ranges from SAR 5,000 (Class D) to SAR 25,000 (Class A) for 1 year, and Authorized Representative license is SAR 2,600 annually.
Question 4: How much does MDMA medical device registration cost with SFDA?
Answer: Fees vary by device class: All Class I and general IVD SAR 15,000, Class II/IIa SAR 19,000, Class IIb/III (CA, PAL) SAR 21,000, Class III/IV and AIMD SAR 23,000. MDMA renewal only SAR 5,000, and minor updates of labels and promotional materials SAR 1,100.
Question 5: What are GMP inspection fees for drug manufacturers by country?
Answer: GMP inspection fees vary by manufacturer location: Saudi Arabia SAR 33,000 (human) / SAR 9,000 (veterinary), GCC countries plus Egypt and Jordan SAR 61,000 / 26,000, Europe and Turkey SAR 121,000 / 56,800, North and South America SAR 161,000 / 112,000, Australia and New Zealand SAR 184,000 / 73,600. These fees apply at registration and renewal every five years.
Question 6: Are there fees for cosmetic product registration with SFDA?
Answer: No, there are no fees for cosmetic product registration in the Electronic Cosmetic Listing System (E-cosma). Similarly, no fees apply for simple food product registration or animal feed product registration. However, special food and dietary supplement registration costs SAR 5,000 per product.
Question 7: How much does drug registration renewal cost?
Answer: New drugs renewal SAR 33,000 total (SAR 30,000 SFDA + SAR 3,000 SDR), generic drugs renewal SAR 11,000, health/herbal product renewal SAR 8,800, veterinary drugs renewal SAR 1,100, intravenous solutions renewal SAR 5,500.
Question 8: How much do SFDA clinical trials and pricing cost?
Answer: Clinical trial license application SAR 15,000, pre-pricing request before registration submission SAR 20,000, pricing objection per registered product SAR 1,000.
Question 9: What is the difference between establishment registration and product registration with SFDA?
Answer: Establishment registration is licensing the commercial entity (factory, warehouse, company) to practice the activity. It is done once with periodic renewal every 5 years typically, with fixed fees (e.g., SAR 10,000 for a pharmaceutical manufacturing plant). Product registration licenses each product individually before it enters the Saudi market, done separately for each product, with fees varying by product type (from SAR 0 for cosmetic products to SAR 95,000 for new drugs).
Question 10: Can a foreign company register with SFDA without a Saudi partner?
Answer: Yes, foreign companies can obtain an investment license from MISA (Ministry of Investment) with 100% ownership, then register with SFDA. Motaded offers an integrated service including the investment license, Commercial Registration, SFDA registration, and Authorized Representative appointment (for foreign medical devices) at SAR 2,600 annually.
Question 11: How long do new establishment registration procedures take with SFDA?
Answer: Duration ranges from 30 to 120 business days depending on the sector and the technical file readiness. Drugs and medical devices in Class III and IV take longer than simple food establishment registration. Motaded shortens this duration by preparing a complete file on the first attempt and avoiding common technical rejection.
Question 12: What are the procedures if my SFDA request is delayed?
Answer: Use the Transactions Inquiry System (mcs.sfda.gov.sa) to track request status, or submit a report through the "Nnjzha" platform (sfda.gov.sa/ar/nnjzha) to track and resolve delayed transactions. Motaded handles this follow-up on behalf of the client as part of the service package.