Saudi Arabia – Time, Cost, and Complexity of Registration
| Device classification in
Saudi Arabia |
Class A
|
Class B | Class C | Class D |
| How long you should expect to wait after submission until approval is granted | 1-3 months | 3-6 months | 3-6 months | 3-6 months |
| Validity period for device registrations | 3 yrs | 3 yrs | 3 yrs | 3 yrs |
| Registration renewal should be started this far in advance | 90 days prior to the expiration date | 90 days prior to the expiration date | 90 days prior to the expiration date | 90 days prior to the expiration date |
| Complexity of the registration process for this classification | Low | Moderate | Moderate-High | High |
| Overall cost of gaining regulatory approval | Low | Moderate | Moderate-High | High |
Determine device classification
Marketing authorization is required before placing a medical device on the Saudi market. Medical devices must obtain authorization through the Saudi Food and Drug Authority (SFDA) under the Medical Devices Regulation and applicable guidance documents.
Devices are typically evaluated based on prior approval in recognized reference markets (e.g., US, EU, Canada, Australia, Japan). The classification in the reference market is generally used to support classification in Saudi Arabia.
Step 1 (all classes) Appoint a Saudi Authorized Representative (AR).
The AR:
- Acts as liaison with SFDA
- Submits applications
- Must be licensed by SFDA
- Holds regulatory responsibility within Kingdom of Saudi Arabia (KSA)
Step 2 (all classes) – Register in GHAD System
- The AR registers the device and company in GHAD, the SFDA electronic system for medical devices.
Step 3 (all classes) – Prepare MDMA Application
Prepare a Medical Device Marketing Authorization (MDMA) submission including:
- Device description and intended use
- Labelling (Arabic + English requirements)
- IFU and promotional materials
- Quality management system evidence (e.g., ISO 13485)
- Proof of approval in a reference market
Step 4 (all classes) – Submit MDMA via Authorized Representative
- The AR submits the MDMA application through GHAD and pays applicable fees
Step 5 (Class B-D) – Technical Review / Conformity Assessment
SFDA may:
- Review the submission directly, or
- Rely on recognized conformity assessment bodies (CABs) for technical review
Step 6 (all classes) – SFDA Decision
- If approved → MDMA certificate issued
- Device is authorized for marketing in Saudi Arabia
Final Step – Market Authorization & Post-Market Compliance
Manufacturers must maintain:
- Valid reference market approval
- Updated technical documentation
- Post-market surveillance obligations
Already Approved in the US, Canada, or Europe? Saudi Arabia Could be Your Next Market. The SFDA requires prior approval from a reference market like the FDA, Health Canada, or CE Mark before granting an MDMA. Qaralogic will manage the full MDMA submission process leveraging the regulatory work you’ve already done to get you to market faster.