FREQUENTLY ASKED QUESTIONS
Questions we hear most from manufacturers.
How long does SFDA registration typically take?
Timelines vary by product category and completeness of documentation. We'll give you a specific estimate for your product during the initial assessment, rather than a generic industry-wide number.
Which product categories do you register?
Infant Formula, Infant Nutrition, Food Supplements, and Medical Nutrition. If your product falls outside these categories, let us know and we'll advise honestly on whether we're the right fit.
Do you handle both new registrations and renewals?
Yes — we manage initial registrations, renewals and variation submissions where they apply, helping you maintain compliance over time.
What happens if a submission is rejected?
We analyse the rejection, identify what must change and manage the agreed next step. Depending on the issue, that may mean correction, reclassification or a new submission. Our classification and label-compliance work at the start is specifically designed to minimise this risk.
Can you help if we're already mid-process with another consultant?
In many cases, yes. We'll review what's been submitted so far and advise on the best path forward.
What do you need from us to get started?
Your product's formulation, its intended category and any documents or label artwork you already have. The initial assessment confirms the regulatory pathway before any paperwork begins, so you learn early what is still missing.
Do we need a Saudi importer or a local responsible party?
In most cases, yes, depending on your market-entry model. A foreign manufacturer typically works through a Saudi-licensed importer or a locally established responsible party that holds the SFDA establishment account. Agree who owns that account and the product record before you appoint a distributor.
Does the label have to be in Arabic?
Yes. Mandatory label information must appear in Arabic under GSO 9; other languages may accompany it if the content is consistent. We review the Arabic label and claims before submission, and ideally before the artwork is final.
What does a classification decision change?
Classification determines the applicable standard, the evidence the file needs, the label text and which claims are allowed. SFDA classifies the finished product on its own criteria, such as ingredients, daily dose, dosage form, intended purpose and claims, so a category accepted in another market does not carry over automatically.