The SFDA is the primary regulatory body in Saudi Arabia responsible for ensuring the safety, efficacy, and quality of medical devices, pharmaceuticals, and cosmetics. The SFDA sets stringent standards to protect public health and facilitate market access for innovative products.
Our Services:
The SFDA regulates the registration, classification, and post-market surveillance of medical devices, ensuring they meet national and international standards for safety and effectiveness, the process done through GHAD Portal.
- Manufacturers Site Registration: Registering the manufacturer’s site for Medical Device Establishment License (MDEL) with the Saudi FDA.
- Marketing Authorization: Securing Medical Device Marketing Authorization (MDMA) with the Saudi FDA on behalf of the manufacturer.
- Regulatory Communication: Liaising with the Saudi FDA regarding any product changes or updates about the manufacturer.
- Post-Marketing Support: Assisting manufacturers with post-marketing and vigilance reporting.
- Product Classification: Classifying products with the Saudi FDA.
- Local Company Registration: Assisting local companies with Medical Device National Registration (MDNR) with the Saudi FDA.
- UDI Submission: Supporting manufacturers with Unique Device Identification (UDI) submission to the Saudi DI database.