It is a governmental certificate issued by the Saudi Food and Drug Authority (SFDA). It is acquired after submitting an application to the authority that contains the product and company files.
The SFDA then reviews its technical and medical content in terms of safety, quality, and efficacy then approve (certify) it. Afterward, a document is issued called SFDA certificate that reflects SFDA approval for the company to market the product in Saudi Arabia.
Products regulated by SFDA are food, medicine (drugs / Pharmaceuticals), and medical devices. In addition to cosmetics, animal health (veterinary), feed/forage, and pesticides.
Commercial activities related to those products are also regulated by SFDA. Therefore, manufacturers, warehouses, and distributors have to receive SFDA licenses before they are able to register the products and receive SFDA certificates.
The below image is an example of SFDA registration certificate for a drug product.
You can refer to our detailed article, SFDA cosmetics registration.
SFDA has a complex way of charging if it is a drug application. But it is simple for other products. For more details about the costs, you may refer to our article SFDA Fees.
- SFDA Registration & Market Regulations
- SFDA Medical Device Registration
- SFDA Drug Registration Requirements & Approval Process
- SFDA Classification
- SFDA Fees
- Cosmetics Registration SFDA (eCosma Requirements)
- SFDA Labelling Requirements
- SFDA Food Supplements Registration
- Medical Device Authorized Representative (SFDA AR)
- Pharmacovigilance & QPPV Requirements in Saudi Arabia