SFDA Classification

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.

Introduction

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:

• 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 a 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 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.

SFDA 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?

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.

SFDA Classification Requirements

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.
• Leaflet/artwork/IFU/catalogue/pictures
• 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

Timelines range between 2 to 10 working days.

Need to Classify your Product?

Contact us for more information.

Read More:

• SFDA Products Registration
• Drug Registration and Approval Process
• Medical Devices Registration
• Pharmacovigilance & QPPV Requirements in Saudi Arabia