This is the most simple procedure at the SFDA where companies can apply to know their product’s SFDA classification. Note that it only clarifies the major class of the product, such as drug, medical device, or food. For example, it will tell if the product is a medical device but will not specify the exact sfda medical device classification.
The SFDA classification rules 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.
- Acceptance: sine some products are not allowed to be marketed in Saudi, such as homeopathic medicines.
- 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 an SFDA registration, especially for products with an 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 normally based on scientific grounds or Saudi-specific regulations. A famous late example is the hyaluronic acid injections that SFDA decided to classify
as priced generic drugs (Update: 8 Oct 2020, SFDA decided to re-classify them as medical device products if they lack advanced claims and additional drug substances).
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 local Saudi companies, who are SFDA licensed, can apply for SFDA classification providing a specific set of documents and an authorization letter from the company (marketing or manufacturing company). Product samples are not needed anymore, 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.
It is SAR 1000 ($266.66) per product classification application.
Timelines ranges between 2 to 10 working days.
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