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Regulatory Editor

Published by regulatory affairs team in PharmaKnowl, Riyadh office.

A product’s classification in Saudi Arabia may differ from that in its country of origin. Therefore, we recommend companies apply for the SFDA classification request in advance, 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, such as a human drug, health product, medical device, pesticide, or food. They will not specify sub-class like risk class (for devices) or dosage form (for drugs). For example, a product may receive confirmation as a medical device. However, the classification response will not specify whether it falls under category A, B, C, or D. The assessment occurs during the device registration phase.

The SFDA classification guidelines actively update the criteria, and the classification outcome provides the following:

Jurisdiction: whether it falls under the SFDA or a different Saudi authority. (e.g., SASO or Ministry of Commerce).
Product type: Whether it is a drug, medical device, food, or cosmetic, based on intended use and mechanism of action.

Is SFDA Classification Mandatory?

Although you can submit an SFDA classification request optionally, it is recommended for borderline or combination products. It helps clarify the regulatory pathway before you begin the registration process.

For example, a product classified as a supplement or cosmetic in its home country may receive a different classification in Saudi Arabia. The SFDA may classify it as a drug or medical device if it has active ingredients or therapeutic claims.

SFDA bases its decision on the product’s intended use, mechanism of action, and composition

Therefore, by confirming classification early, companies reduce the risk of submitting to the wrong department. This saves time, prevents delays, and supports smoother regulatory approval.

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
Animal general care products (Grooming)
Products for Clearance
Products not under SFDA’s Jurisdiction (NSFDA)

How to Apply for SFDA Classification?

Only SFDA-licensed Saudi companies can apply for a classification request. Applicants must file through the Electronic Product Classification System (ePCS) with all the necessary documents uploaded in the specified format. There is no need to provide physical product samples.

Electronic Product Classification System (e-PCS) Process

When a product’s regulatory category is not clearly defined or when it is a new or borderline product, applicants must use the Electronic Product Classification System (ePCS). Through this platform, users can:

Submit product classification requests
Track application status
Receive official classification letters valid for one year
Appeal decisions within 30 calendar days with supporting scientific or regulatory justification.

Flowchart

Step 1. Company Sign-Up service: Create an ePCS account with company details and an authorization letter

Step 2. Product Classification Service:
Submit classification application with required documentation. Pay the applicable fee.
The application will be assessed based on the receipt.

Step 3. Classification Decision: The final decision will be emailed and valid for one year after the product’s classification is approved.

Step 4. Appeal Service: The applicant can appeal against the decision within 30 calendar days of receiving the final decision by submitting the regulatory or scientific justifications supporting the appeal.

Required Documents for Classification

The following list summarizes the document requirements:

Full product composition and specifications.
Labeling and artwork materials
Scientific literature or pharmacopoeia references
Justification of intended use and mechanism of action
Reference classifications from other regulatory authorities (if applicable)
Authorization letter (from the product owner or MAH)
Valid SFDA license of the applicant
Payment of classification fees. For the amount, refer to our detailed article: SFDA Fees.