Service overview
What is MDMA Registration
MDMA (Medical Device Marketing Authorization) is the official authorization issued by SFDA for every medical device or medical product before entering the Saudi market. Without MDMA, no warehouse, hospital, pharmacy, or e-commerce platform in the Kingdom is permitted to store or sell the device. Violations expose the company to immediate confiscation, financial penalties, and establishment license revocation.
The Four Classes and Their Impact on Fees and Requirements
| Class | Risk Level | Government Fee | Examples |
|---|---|---|---|
| Class A | Low | SAR 15,000 | Surgical bandages, simple examination tools, medical chair |
| Class B | Moderate | SAR 19,000 | Cannula, syringes, catheter tubes, blood pressure monitors |
| Class C | High | SAR 21,000 | Ventilators, anesthesia, active surgical devices |
| Class D | Very High | SAR 23,000 | Implantable devices, heart valves, artificial joints |
Note: All fees are subject to 15% VAT above the base amount. Classification follows SFDA rules similar to EU MDR 2017/745.
The Substantive 2022 Shift — MDMA2 the Only Pathway
Before 2022, manufacturers had two routes: the GHTF Route (MDMA1) which accepted CE certificates from EU or FDA approval from USA as basis for registration, and the MDNR for low-risk devices without AR requirement. SFDA cancelled both routes: GHTF Route in end of 2021, and MDNR in September 2022. Since January 2022, MDMA2 became the only pathway for all devices in all classes, requiring complete Technical File Assessment (TFA) via the GHAD system.
Requirements per Class
| Technical File | Class A | Class B | Class C | Class D |
|---|---|---|---|---|
| Device Description & Intended Use | ✓ | ✓ | ✓ | ✓ |
| Risk Analysis (ISO 14971) | ✓ | ✓ | ✓ Detailed | ✓ Highly Detailed |
| Quality System (ISO 13485) | ✓ | ✓ | ✓ | ✓ |
| CE / FDA Certificate | Preferred | Preferred | ✓ Strongly Recommended | ✓ Strongly Recommended |
| Pre-Clinical Studies | Not Required | Device-Dependent | ✓ Required | ✓ Required |
| Clinical Studies / CER | Not Required | Device-Dependent | ✓ Required | ✓ Required Extensive |
| Biocompatibility Study | Device-Dependent | Device-Dependent | ✓ Required | ✓ Required |
| Stability Study | ✓ | ✓ | ✓ Extended | ✓ Extended |
| Post-Market Surveillance Plan (PMS) | ✓ | ✓ | ✓ Detailed | ✓ Detailed + PMCF |
MDMA Registration Stages
The procedure proceeds through six stages: First — initial consultation and precise device classification (incorrect classification is a primary cause of rejection). Second — Gap Analysis: comparing the manufacturer's available file against SFDA requirements to determine what needs preparation. Third — preparing the complete Technical File Assessment (TFA) per MDS-REQ 1. Fourth — filing via the GHAD system with the Authorized Representative. Fifth — fee payment according to class after receiving the SFDA invoice. Sixth — responding to SFDA technical inquiries until MDMA certificate issuance in Arabic and English in the manufacturer's name.
Complete Government Fees
| Item | Amount | Notes |
|---|---|---|
| MDMA Class A | SAR 15,000 | + 15% VAT |
| MDMA Class B | SAR 19,000 | + 15% VAT |
| MDMA Class C | SAR 21,000 | + 15% VAT |
| MDMA Class D | SAR 23,000 | + 15% VAT |
| Certificate Renewal (any class) | SAR 5,000 | Every 3 years |
| Minor Label / IFU Update | SAR 1,100 | Per update |
| Larger Modifications | Per schedule | Varies by modification type |
Why Motaded for MDMA Registration
We have a specialized team in preparing MDMA files across all four classes, with experience handling SFDA technical inquiries. We conduct detailed Gap Analysis before submission to reduce rejection probability, and we provide the Authorized Representative (AR) service as an integrated package. For comprehensive educational overview of MDMA procedure, see our complete guide on the Blog page. For overview of all SFDA services, see the SFDA platform page.
Packages and Pricing
| Package | Price | Inclusions |
|---|---|---|
| MDMA Class A | SAR 22,000 | Single Class A device registration + Gap Analysis + TFA preparation + GHAD filing + SFDA inquiry handling + MDMA certificate in your name + SAR 15,000 government fee |
| MDMA Class B | SAR 28,000 | Everything in Class A + deeper technical file + more inquiry management + SAR 19,000 government fee |
| MDMA Class C | SAR 32,000 | Everything above + pre-clinical studies preparation + PMS plan + complex inquiry management + SAR 21,000 government fee |
| MDMA Class D | SAR 38,000 | Everything above + CER clinical studies + detailed PMCF plan + SAR 23,000 government fee |
| MDMA Renewal (any class) | SAR 7,500 | Certificate renewal 3 months before expiry + update for changes + SAR 5,000 government fee |
| Minor Update (Label / IFU) | SAR 2,500 | Update data in SFDA + document preparation + SAR 1,100 government fee |
| Additional Services | Case-by-case | Independent CER preparation, AR service (annual), expanded regulatory advisory, re-submission after rejection |
Multi-Device Discounts
| Number of Devices (same class) | Discount | Notes |
|---|---|---|
| 1 device | No discount | Full price |
| 2-5 devices | 10% | Discount on additional devices only |
| 6-15 devices | 15% | Coordinated management as single package |
| 16+ devices | 20% | Separate account with dedicated account manager |
Package Inclusivity
| Item | Status |
|---|---|
| Full SFDA government fees | ✓ Covered |
| Complete TFA preparation per MDS-REQ 1 | ✓ Covered |
| SFDA inquiry handling until issuance | ✓ Covered |
| Authorized Representative AR service | ✗ Separate service |
| Independent CER preparation (required for C/D) | ✗ Separate service |
| On-site clinical studies | ✗ Paid by manufacturer |
| 15% Value Added Tax | ✗ Added to price |
Service snapshot
Medical Device Manufacturers
GHAD System
Duration & Validity
Objectives
We classify your device precisely and prepare a TFA compliant with MDS-REQ 1 to minimize rejection probability.
Your certificate in Arabic and English in the manufacturer's name, remains yours even when changing AR.
We provide AR + MDMA + clearance as integrated package to avoid distributor conflicts.
Work Tracks
Classification and Gap Analysis
TFA Preparation
Filing and Inquiry Management
Post-Issuance
Steps to Obtain
Areas of Work
We register your new devices in the Saudi market with complete TFA from scratch.
We manage MDMA renewal every 3 years, and technical updates on data and labels.
Extra data
Low-Risk Device Registration (Class A)
We register low-risk devices quickly with simplified file and SAR 15,000 fee.
Moderate Device Registration (Class B)
We prepare moderate-depth TFA for injections, tubes, and catheters at SAR 19,000.
High-Risk Device Registration (Class C)
We register ventilators and anesthesia with complete clinical studies and expanded technical file at SAR 21,000.
Very High-Risk Device Registration (Class D)
We register implantable devices, heart valves, and artificial joints with complete CER and detailed PMCF plan at SAR 23,000.
MDMA Certificate Renewal
We handle certificate renewal before the 3-year expiry at SAR 5,000 government fee.
Integrated AR + MDMA Package
We provide Authorized Representative + MDMA registration + clearance as unified package from single point of contact.
FAQs
- How long does MDMA take?
Review 35 days, actual issuance 2-14 months depending on class.
- Do I need AR before MDMA?
Yes mandatory for foreign manufacturers since September 2022. Motaded offers as integrated package.
- Is CE certificate sufficient?
No, GHTF Route cancelled by SFDA. Only pathway is MDMA2 with complete technical file.
- How long is MDMA validity?
3 years renewable. Renewal fee SAR 5,000 only without resubmitting full file.
- Do I own my certificate?
Yes, issued in manufacturer's name and remains your property. Transfers when changing AR.
