SFDA Product Classification

Companies can apply for a product classification at the Saudi Food and Drug Authority (SFDA) based on the SFDA classification rules. The outcome of the classification confirms the following:

  • Jurisdiction: whether it falls under the SFDA’s or a different Saudi authority.
  • Acceptance: some products are not allowed to be marketed in Saudi such as homeopathic medicines.
  • Product type: based on this core feedback, the company knows which SFDA sector and registration pathway they should take to market their product.

Therefore, starting with product classification is important to confirm the type in Saudi; therefore, it provides verification and prevents waste of time and budget.

Although submitting a classification request is optional, it is highly recommended before planning for SFDA product registration for those with an unclear type due to intersection in the definitions such as borderline products and unique combinations.

For example, a product that is 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 which SFDA decided to classify them as priced generic drugs (Update: as of 8 Oct 2020, SFDA decided to classify them as medical device products if they’re lacking advanced claims and additional drug substances).

Classification Types

  • Drug
    • Human Pharmaceutical Drug
    • Biological Medicinal Product
    • Veterinary Drug
  • Health Product
  • Herbal Medicine
  • Medical Device Classifications
    • Medical Devices
    • IVD
    • 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
  • Tobacco
  • Animal Feed & Pesticide

How to apply for SFDA classification?

Local Saudi licensed companies can apply for SFDA classification providing a specific set of documents and official letters. Applicants must register and apply through the SFDA Products Classification System (PCS).

SFDA Classification Requirments

The classification requirements are summarized in the following list:

  • Detailed Product Information/composition/ingriedints/part.
  • Manufacturer Information & documents
  • Indication or purpose of use
  • Mechanism of action (mode of action)
  • Countries in which the product is marketed.
  • Leaflet/artwork/IFU/catalog/pictures
  • Application form
  • Letters from the manufacturer
  • Certificates: Registration in COO/GMP/Quality/Conformity/etc
  • List of countries where marketed.

Fees

It is SAR 1000 ($266.66) per product classification application.

Timelines

Timelines ranges between 5 to 10 working days.

Need to Classify your product?

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