SFDA registration: steps, documents, fees & timelines.
A visual, source-cited walk-through of the five SFDA registration pathways — drugs, medical devices, cosmetics, food/supplements and herbal. For each: the process steps, the documents you must assemble, the indicative fees, and how long it really takes.
The whole landscape on one screen
Skim the five SFDA pathways side by side, then jump into any category for the full step-flow, document checklist, fee table and timeline. Every SAR figure below is indicative and flagged for verification.
| Category | Nature | Key gate | Statutory clock | Headline fee | Jump |
|---|---|---|---|---|---|
| 1. Drugs / Pharmaceuticals | Full scientific review — CTD/eCTD dossier + GMP inspection + pricing. | GMP site inspection + pricing decision | 35 business days S2 | New drug ≈ SAR 95,000 + 20,000 eSDR to verify | Open → |
| 2. Medical Devices | Risk-classed technical-file review (Class A–D), via MDMA e-Service. | MDEL + ISO 13485 in place before you can file | 35 working days S6 | Class III/IV ≈ SAR 21,000–23,000 S3 | Open → |
| 3. Cosmetics | Notification / listing (self-declaration) — not a scientific review. | No fee — but you need a local notifier | ~15 working days to verify | Notification = no SFDA fee S5·S7 | Open → |
| 4. Food / Supplements | A classification fork: Food Sector (special food) vs Drug Sector (health/herbal). | Classification: Food Sector vs Drug Sector | 5 working days S2 | Supplement ≈ SAR 5,000 (food path) to verify | Open → |
| 5. Herbal / Health Products | Drug-like pathway under the same Registration Rules — health/herbal fee tier. | GMP inspection + CTD dossier (drug-like) | ~35 business days S2 | Registration ≈ SAR 20,000 + 4,000 eSDR to verify | Open → |
What a first registration roughly costs
Indicative headline registration fees by category (ex-VAT, per product). Cosmetics carry no SFDA registration fee — every other bar is a draft figure to confirm against the primary SFDA schedule.
Drugs / Pharmaceuticals
Full scientific review — CTD/eCTD dossier + GMP inspection + pricing.
Foreign companies without a Ministry of Investment licence appoint a local agent (and may contract a warehouse) per product to be marketed.
Submit GMP certificate from the country-of-origin authority, periodic-inspection proof, product list, Site Master File and the production lines to register; pay inspection fees.
SFDA inspects the manufacturing site — mandatory before final product approval.
File the complete CTD/eCTD (Modules 1–5) in SDR per SFDA guidelines.
SFDA may rely on a Stringent Regulatory Authority assessment under the Regulatory Framework for Drugs Approval — reliance/abridged routes can shorten review.
Quality and clinical assessment, with inquiry / Additional-Information-Request (AIR) rounds answered by the applicant.
Submit the pre-pricing request; SFDA issues a price decision on an external-reference-pricing basis.
MA issued and the product is listed in SDR.
The 35-business-day clock is SFDA's target once the file is accepted as complete (official, S2). Real timelines run longer — GMP scheduling, AIR rounds and pricing dominate (S9 · S10).
Medical Devices
Risk-classed technical-file review (Class A–D), via MDMA e-Service.
Mandatory for foreign manufacturers — an SFDA-licensed AR fronts the submission.
The local establishment must hold a Medical Device Establishment Licence and run an ISO 13485 QMS.
Classify the device (A–D) or IVD (A–D) under the SFDA / IMDRF risk rules.
Check the technical documentation against SFDA Essential Principles before filing.
Register the device + manufacturer and upload the technical file on the MDMA e-Service.
SFDA validates the submission format, issues an invoice, and you pay the fees.
Technical assessment and inquiry rounds; a site audit may be scheduled for higher classes.
Authorization granted — certificate valid 3 years.
Certificate valid 3 years; apply up to 180 days before expiry (S6). Real end-to-end stretches from ~2 months (simple Class A) to 14+ months (Class D implantables) once AIRs, fee processing and site audits are counted (S11 · S12).
Cosmetics
Notification / listing (self-declaration) — not a scientific review.
Only a local company (importer / local service provider) can notify; foreign brands work through them.
Gather full INCI list and concentrations; confirm no prohibited ingredients.
Enter the product in GHAD / eCosma with the complete ingredient list & functions.
SFDA does not pre-review the file — the notifier declares conformity.
SFDA decision / listing certificate granted.
Obtain a CoC pre-shipment and comply with Arabic labeling at the border.
Notification is free (HIGH confidence, S5 · S7 · S13). The ~15-working-day decision is from consultancy sources (MEDIUM). Listing-certificate validity is not stated in the sources — verify.
Food / Supplements
A classification fork: Food Sector (special food) vs Drug Sector (health/herbal).
The pivotal first decision: Food Sector (standard vitamins/minerals within limits) vs Drug Sector (exceeds the daily limit or makes a medical/non-approved claim — needs a CTD file).
Foreign manufacturers appoint a Saudi Authorized Representative.
Register in the food system with ISO certs, SDS, labels/artwork and ingredient-safety certificates; comply with GSO / Arabic labeling.
Submit a CTD/eCTD per ICH; a GMP inspection of the manufacturer is required.
Assessment and inquiry rounds along the chosen pathway.
Certificate granted for the product.
Food-sector processing times are now SFDA-official (S16): traditional food 5 working days, energy drinks 20, and supplements / special-dietary / special-medical / infant / novel foods 90 working days (cumulative within SFDA). Drug-sector routing instead follows the slower drug clock (months).
Herbal / Health Products
Drug-like pathway under the same Registration Rules — health/herbal fee tier.
Foreign companies appoint a local agent.
GMP (or herbal-equivalent) certificate, Site Master File and inspection fees.
SFDA inspects the manufacturing site.
File the dossier (per ICH) in SDR.
Confirm herbal vs health classification.
Safety / efficacy and quality review, with inquiry rounds.
Registration issued (conditional or full).
Shares the drug clock — statutory target ~35 business days once complete (S2 frame, HIGH on the figure). Realistic timelines run to months given GMP + reviews (S8).
Supplements: which sector are you on?
A food supplement is routed to one of two SFDA sectors — and that single classification changes the process, the dossier, the fee and the timeline. It is the most common point of confusion, with the biggest BD consequence.
- Food-system registration (ISO certs, SDS, labels/artwork)
- GSO + Arabic labeling
- Fee ≈ SAR 5,000 to verify
- Full CTD/eCTD dossier, like a drug
- GMP inspection of the manufacturer
- Health/herbal fee tier (≈ SAR 20,000) to verify
The exact daily-limit cut-offs and allowed-claim boundaries are not pinned down in the sources used here — treat the fork logic as directional and confirm the thresholds against the primary SFDA food/drug classification rules before acting. to verify
This guide is a working draft. The medical-device evaluation fees are now confirmed against the primary SFDA fee table (S3); the list below is the set of figures and facts still to re-check against the primary SFDA source (the drug fee schedule and the GHAD / drug-sector portals) before anyone treats them as final.
- STILL OPEN (hard blocker) — the primary SFDA DRUG/HERBAL product fee schedule does not appear to be public. Registration Rules V4 (S1) explicitly defer fees to 'a separate regulation' that is not published; the official MA-fees FAQ (S2) links only the DEVICE table (S3). Drug/herbal SAR lines remain consultancy-only (S5/S9; corroborated by AllCare, Motaded, Freyr). Re-check GHAD's authenticated fee screen and any future SFDA fee circular.
- STILL OPEN — 15% VAT-on-top treatment is consultancy-stated only; no primary SFDA line found. Confirm before presenting VAT as fact.
- DONE — SUPPLEMENT and food-sector fees/timelines verified to primary SFDA guides (S16/S17); COSMETIC establishment licence fees verified (S18).
- Replace the {VERIFY DATE} placeholder and date-stamp the page on publish.
- STILL OPEN — every drug SAR fee line (new 95k, generic 40k, IV fluids 15k, vet 5k, renewals, variation, GMP inspection) is consultancy-reproduced (S5/S9). No primary SFDA drug fee document located; do NOT upgrade to high without one.
- Pre-pricing PROCESS is now primary-confirmed (S19, Pharmaceutical Pricing Rules) but the SAR 20,000 AMOUNT is not stated there — amount stays medium.
- Confirm the MA review target is still 35 business days (S2, official) and that eSDR add-ons still apply.
- DONE — Class I–IV evaluation fees (FG1–FG4: 15 / 19 / 21 / 23k) confirmed against the primary SFDA MDMA fee table (S3); 35-day clock with them.
- Still verify the renewal (5,000), add-device (5,000), AR-licence (2,600) and MDEL fees — not in S3, currently consultancy (S6).
- Confirm MDMA validity (3 yrs), the 180-day renewal window, and that ISO 13485 + MDEL remain mandatory (S4 · S6).
- DONE — cosmetic establishment licence fees (factory 5,000 / warehouse 3,000) verified to primary SFDA guide (S18). Notification = no fee stays high.
- STILL OPEN — the ~15-working-day notification decision and the listing-certificate validity are still consultancy-only; confirm GHAD vs eCosma current entry point.
- DONE — SAR 5,000 supplement/energy-drink fee, +500 add-size, no-expiry, and food-sector processing times (5/20/90 working days) all verified to primary SFDA Food Registration guides (S16/S17).
- STILL OPEN — 'simple/traditional food = no fee' is implied (S16 lists no fee for it) but not explicitly stated; left medium.
- STILL OPEN — highest-risk: confirm the exact Food-vs-Drug classification thresholds (daily-limit cut-offs, allowed claims).
- STILL OPEN — health/herbal registration (20,000 + 4,000 eSDR), renewal (8,000) and the add-form/strength/pack lines are consultancy-only (S5/S9). Same blocker as drugs: no primary SFDA herbal product fee schedule located.
- Confirm the CPP-from-SRA requirement is still current under the latest Regulatory Framework for Drugs Approval (S1).
Where every figure comes from
Official SFDA sources are marked in green. The medical-device evaluation fees (Class I–IV: SR 15,000 / 19,000 / 21,000 / 23,000) are confirmed against the primary SFDA fee table (S3). The drug, herbal and supplement SAR fees are drawn from S5 (PharmaKnowl, Aug 2025) and still await line-by-line confirmation against the primary SFDA drug fee schedule. The 35-business-day drug MA clock is confirmed on the primary SFDA source (S2).
This guide is informational and not legal, regulatory or medical advice. SFDA requirements, fees and review times change frequently and vary by product sub-type, risk class and reliance pathway — always confirm against the official SFDA portals and the current fee schedule before filing. RaqibHealth cites SFDA on every record. info@raqibhealth.com · RaqibHealth home