Premium SFDA expertise.
Transparent fixed rates.
Riyadh-based licensed consultancy delivering end-to-end approval for medical devices, IVDs, and cosmetics. We publish our complete fixed-rate schedule upfront — eliminating hidden charges and query delays.
> MDMA from $2,500 · AR from $260 · PCS from $200
Why manufacturers choose EMMCR
Published fixed-rate pricing — the full fee schedule is public, in USD and SAR.
SFDA-authorized and licensed — a legally recognized Authorized Representative in KSA.
One dedicated consultant per submission, from classification to approval.
Government fees itemized separately — you always see what goes to the SFDA.
The SFDA Regulatory Pathway
Every stage of Saudi market entry, managed in sequence — and in parallel where the rules allow.
PCS Classification
Product Classification System determinationAR Agreement
Authorized Representative appointmentMDMA
Medical Device Marketing AuthorizationUDI Registration
Unique Device Identification complianceMDIL & MDEL
Import, distribution & export licensingTransparent service pricing
Every fee published upfront — fixed rates in USD and SAR. SFDA government fees are always itemized separately, so you see exactly what goes to the regulator.
| Service | USD | SAR |
|---|---|---|
| New AR Agreement | 260 | 975 |
| New MDMA Application | 2,500 | 9,375 |
| AR Renewal | 260 | 975 |
| MDMA Renewal / Update | 1,200 | 4,500 |
| MDEL Renewal | 1,200 | 4,500 |
| PCS Classification | 200 | 750 |
| UDI Registration | 2 / UDI | 7.50 / UDI |
| MDIL License | 300 | 1,125 |
Big firm vs EMMCR
Typical market quotes for the same SFDA services*
*Indicative ranges based on publicly available market quotations for comparable SFDA consultancy services; individual quotes vary. EMMCR fees exclude SFDA government charges, which are passed through at cost and itemized in every quotation. VAT (15%) applies to consultation fees.
Full AR + MDMA Starter Package
New Authorized Representative agreement ($260) plus a complete new MDMA application ($2,500) — everything a foreign manufacturer needs to legally enter the Saudi market, handled by one dedicated consultant.
How we support SFDA compliance
We assist clients across the full SFDA regulatory lifecycle — each service at a published fixed rate.
PCS Submissions
Product Classification System applications establishing the correct regulatory route for each device.
Fixed rate: $200MDMA Applications
Medical Device Marketing Authorization — full dossier preparation, submission, and query management.
Fixed rate: $2,500 new · $1,200 renewalAR Agreements
Authorized Representative arrangements giving international manufacturers a licensed legal presence in KSA.
Fixed rate: $260 new or renewalMDIL & MDEL Licensing
Import, distribution, and export licensing for compliant movement of devices in and out of the Kingdom.
Fixed rate: $300 MDIL · $1,200 MDEL renewalUDI Registration
Unique Device Identification compliance, including bulk registration for multi-device portfolios.
Fixed rate: $2 per UDICosmetics Registration
Complete cosmetic product compliance, from notification through listing and ongoing maintenance.
Quoted per portfolio — always fixedPremium expertise, without the premium invoice
Value-focused, trust-building regulatory expertise at cost-effective rates.
Minimized delays
Proactive query management and compliant strategy reduce approval timelines significantly.
High approval success
Strong command of SFDA classification rules and device bundling for optimal outcomes.
Complex portfolio experience
Practical handling of multi-device portfolios with efficient application structuring.
Dedicated consultants
A single point of contact manages each submission from start to finish.
Reduced rework
Clear documentation mapping aligned with SFDA folder structures from day one.
Regulatory predictability
Compliant strategy development that avoids rejection risk and ensures long-term compliance.
Compliant strategy
Proper classification and correct application structuring on every submission.
Dedicated consultant
Single point of contact with full accountability and consistent quality.
Service categories
Complete support across medical devices, IVDs, cosmetics, and other regulated products.
We are EMMCR
EMMCR is a Saudi FDA-authorized and licensed consultancy based in Riyadh. We assist manufacturers and distributors across medical devices, IVDs, cosmetics, and other regulated products by aligning technical documentation, strategy, and submissions with SFDA regulations.
Our team prioritizes precision in classification, application structure, and query management — ensuring swift approvals and long-term compliance at rates every manufacturer can see before they commit.
Ready to navigate SFDA compliance with confidence?
Send us your product list — we reply with the classification view, the regulatory route, and a fixed, itemized quotation.
- Emailregulatory@emmcr.com
- Phone+966 544 419 854
- AddressRiyadh, Kingdom of Saudi Arabia
- CR No.1009194822
- VAT No.312859286600003
Get your fixed quote in 24 hours
Tell us your products and target timeline. You will receive a complete quotation with consultation fees and SFDA government fees itemized separately — the same transparent rates published on this page.
Request a fixed quote