In Saudi Arabia, the product class according to the SFDA classification does not necessarily match its class in its country of origin. Therefore, we recommend companies apply for the SFDA classification, especially if the product class isn’t specified in the classification guidelines. This helps companies know their official product classification in Saudi Arabia and avoid investing in the wrong SFDA registration application.
In the classification procedure, it is essential to note that SFDA will only clarify your product’s primary class. The feedback will direct the applicant to apply as a human drug, health product, medical device, pesticide, or food. This means they will not detail the sub-class. For example, if it is a medical device, then you should not expect to receive information about the exact SFDA medical device classification.
The criteria are being actively updated in the SFDA classification guidelines, where the outcome of the classification provides the following:
Although submitting an SFDA classification request is optional, it is highly recommended before submitting your SFDA registration file. Especially for products with unclear types due to the intersection in the definitions, such as borderline products and unique combinations.
For example, a cosmetic product in its country of origin might be classified as a medical device or even a drug in Saudi Arabia. The classification decision is based on scientific grounds and regulations related to labelling, claims, and ingredients. A famous late example is hyaluronic acid injections (filler), which the SFDA classifies as generic drugs to control their prices. (Update: On 8 Oct 2020, the SFDA decided to reclassify them back to medical device products.)
Therefore, starting your regulatory project with a product classification is essential to confirm the type in Saudi; consequently, it verifies the procedure to save time and budget.
Only SFDA-licensed Saudi companies can apply for classification. They must provide specific documents and an authorization letter from the marketing company. The good news is that SFDA is no longer requires product samples, it’s just a paperwork procedure.
The classification requirements are summarized in the following list:
Timelines range between 2 to 10 working days.
Contact us for more information.
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