Navigating the SFDA fees for medical devices is critical to achieving compliance and entering the Saudi Arabian market. The Saudi Food and Drug Authority (SFDA) outlines specific fee structures and timelines based on device classifications, application updates, and authorized representative requirements.  

Timelines, and Requirements for SFDA Fees for Medical Devices

1. Device Classification and Fees 

SFDA fees for medical device marketing authorization (MDMA) vary by risk classification​: 

• Class A (Low Risk): SAR 15,000, with a review time of 35 working days. 

• Class B (Moderate Risk): SAR 19,000, with a review time of 35 working days. 

• Class C (High Risk): SAR 21,000, with a review time of 35 working days. 

• Class D (Very High Risk): SAR 23,000, with a review time of 35 working days. 

These fees ensure a thorough evaluation based on the safety and risk level of the device. 

2. Updates to MDMA Applications 

For modifications to existing MDMA applications, the SFDA has categorized fees based on the type of update​: 

• Adding devices/models: SAR 5,000 (reduced fees). 

• Instructions for Use (IFU) updates: SAR 1,100 (administrative fees). 

• Label updates: SAR 1,100 (administrative fees). 

• Update advertising materials: SAR 1,100 (administrative fees). 

• Changes to device design: SAR 5,000 (reduced fees). 

• Brand name change: SAR 5,000   

• Jurisdiction or classification changes: Full fees apply. 

• Renew design examination: SAR 1,500 

• Change jurisdiction: Full fees apply. 

• Change classification: Full fees apply. 

• Change manufacturer address/name: Full fees apply. 

• Minor change manufacturer name or address: 5000 SAR 

• Change notified body:   Full fees apply. 

• Change Notified Body with a transition period letter: 5000 SAR 

• Change notified body due to Brexit (Same NB different number) : 5000 SAR 

Timely updates are crucial to maintaining compliance with SFDA guidelines. 

3. Authorized Representative Applications 

Foreign manufacturers without a legal entity in Saudi Arabia must appoint an authorized representative. Application fees and review times for these representatives are integral to the approval process​. 

Key Takeaways 

Understanding the SFDA fees for medical devices ensures manufacturers can plan effectively for compliance costs. From classification-based evaluations to application updates and representative fees, the SFDA’s structured approach promotes safety and quality across the medical device sector. 

For more details on SFDA fees for medical devices or support with your application, consult with experienced regulatory consultants to streamline your entry into the Saudi market. 

Frequently Asked Questions (FAQs): SFDA Fees for Medical Devices

1. How are SFDA fees determined for medical device registration? 

SFDA fees for medical devices are based on the risk classification of the device, with fees ranging from SAR 15,000 for Class A devices to SAR 23,000 for Class D devices. 

2. What are the fees for updating an existing MDMA certificate?  

Fees for updates depend on the type of change. For instance, adding devices or models costs SAR 5,000, while label or IFU updates cost SAR 1,100. 

3. Do SFDA fees include post-market obligations?  

No, SFDA fees cover the registration and evaluation process. Manufacturers and authorized representatives must manage post-market obligations separately. 

4. Are SFDA fees refundable if an application is rejected?  

Typically, SFDA fees are non-refundable. It is crucial to ensure that all submissions meet the required standards to avoid rejection. 

5. Can fees vary for foreign manufacturers?  

Fees are standardized regardless of whether the manufacturer is local or international. However, foreign manufacturers must appoint an authorized representative, which involves additional costs.

6. How long does it take to process applications after fees are paid? 

The processing time varies by device classification, with most applications reviewed within 35 working days.