In Saudi Arabia, the SFDA classification of products will not necessarily be the same as the product class in its country of origin. Therefore, there is a simple classification procedure that applies the SFDA classification guidelines or decide for those types not mentioned in the guidelines. Submission through this procedure helps companies know their official product classification in Saudi.
It is important to note that SFDA will only clarify your product major class. The feedback will be human drug, health product, medical device, pesticide, or food. Meaning, 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:
- Jurisdiction: whether it falls under the SFDA or a different Saudi authority.
- Product type: This is the core classification feedback; the company will know if their product is food, drug, or medical device.
Is SFDA Classification Mandatory?
Although submitting an SFDA classification request is optional, it is highly recommended before submitting your SFDA registration file. Especially for products with unclear type due to the intersection in the definitions, such as borderline products and unique combinations.
For example, a product classified as 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 the hyaluronic acid injections (filler) where SFDA classify them
as generic drugs to control their prices. (Update: in 8 Oct 2020, SFDA decided to re-classify them back to be medical device products).
Therefore, starting your regulatory project with a product classification is important to confirm the type in Saudi; therefore, it verifies the procedure to save your time and budget.
SFDA Classification Types
- Human Pharmaceutical Drug
- Biological Medicinal Product
- Veterinary Drug
- Health Product
- Herbal Medicine
- Medical Device Classifications
- Medical Devices
- Non-Medical IVD
- Chemical for Medical Use
- Distillation Device
- General Lab Use
- HCT/Ps Product
- Radiation Device
- Food Product
- Cosmetic Product
- Combination Product
- Integrated combination product
- Non-integrated combination product
- Borderline Product
- Animal Feed & Pesticide
How to Apply for SFDA Classification?
Only SFDA approved Saudi companies can apply for classification. The need to provide a specific set of documents in addition to 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.
SFDA Classification Requirments
The classification requirements are summarized in the following list:
- Detailed Product Information/composition/ingredients/part.
- Manufacturer Information & documents
- Indication or purpose of use
- Mechanism of action (mode of action)
- Countries in which the product is marketed.
- Application form
- Letters from the manufacturer
- Certificates: Registration in COO/GMP/Quality/Conformity/etc.
- List of countries where marketed.
- Payment of classification fees. For the amount, refer to our detailed article: SFDA Fees.
Timelines ranges between 2 to 10 working days.
Need to Classify your Product?
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