Understanding SFDA Requirements for Medical Devices and Cosmetics in Saudi Arabia

Saudi Arabia is one of the most regulated and fast-growing markets in the Middle East, especially in the aesthetic, medical, and cosmetic sectors. For international brands planning to enter the Kingdom, understanding the Saudi Food & Drug Authority (SFDA) requirements is essential for a smooth, compliant, and successful market entry.

This article provides a clear and practical overview of how SFDA regulates medical devices, dermal fillers, cosmetics, and skin care products, and what manufacturers must prepare before launching in Saudi Arabia.

1. Regulatory Categories Under SFDA

Every product entering Saudi Arabia must be classified correctly. SFDA generally divides aesthetic-related items into two main categories:

A) Medical Devices

Includes:

• Dermal fillers.

• Skin boosters.

• Threads.

• Laser and energy-based devices.

• Micro needling devices.

• Class II & III medical products.

These require Medical Device Marketing Authorization (MDMA).

B) Cosmetics

Includes:

• Skincare products (serums, creams, masks…)

• Hair care

• Cleansers

• Body care

• OTC (Over The Counter) beauty products

These require Cosmetic Product Notification (CPN).

Proper classification from the beginning avoids delays, rejections, or extra fees.

2. Requirements for Medical Device Registration (MDMA)

Medical devices are regulated more strictly due to their clinical nature.

Key requirements:

1. Valid regulatory approval in another recognized market (e.g., CE, FDA, MDSAP).

2. Technical File including safety, clinical data, risk analysis, biocompatibility, labeling, and instructions for use.

3. Authorized Representative (AR) in Saudi Arabia responsible for compliance (usually your distributor or a specialized regulatory company).

4. UDI (Unique Device Identifier) for traceability.

5. Listing the device on the GHTF-based Saudi database.

6. Facility licensing for importers and distributors.

Expected timeline:

3 to 9 months depending on product class and documentation quality.

3. Requirements for Cosmetic Product Notification (CPN)

Cosmetics follow a simpler but still regulated pathway.

Key requirements:

1. Artwork and labeling compliant with GCC and SFDA guidelines (ingredient list, Arabic information, warnings).

2. Safety Assessment / CPSR

3. Lab test results (microbiology, stability, heavy metals, etc.).

4. Free Sale Certificate from the country of origin.

5. Product formula and allergens declaration.

6. Gulf Conformity Barcodes (GTIN).

7. Online notification through eCosma system.

Expected timeline:

1 to 4 weeks per product, depending on documentation.

4. Facility and Import Requirements

Before any shipment enters Saudi Arabia:

• Importer must hold Medical Device Establishment License (MDEL) for devices.

• Cosmetic importer must hold Cosmetic Warehouse License.

• All shipments must be released through the Fasah system.

• Products must be barcoded and traceable.

• Labeling must match what was approved during registration.

5. Common Mistakes That Delay Approvals

Many brands face obstacles because they are unaware of SFDA expectations.

Common mistakes include:

• Incorrect product classification.

• Missing clinical evidence for fillers or devices.

• Artwork without Arabic labeling.

• Incomplete technical file documentation.

• Trying to register cosmetics as “cosmeceuticals” (no such category exists in SFDA).

• Using a distributor who lacks regulatory experience.

• Submitting inconsistent data across certificates and labels.

Avoiding these mistakes saves months of delays and additional costs.

6. How Synners Supports Brands with SFDA Compliance

Synners helps international companies navigate SFDA requirements with full clarity and efficiency.

Our services include:

• Product classification assessment.

• Complete registration and documentation handling.

• Technical file preparation support.

• Labeling review and Arabic translation.

• Selecting or verifying the right local distributor.

• End-to-end regulatory strategy planning.

• Ensuring full compliance before import.

With our deep experience in the Saudi aesthetic and medical sectors, we ensure your products enter the market smoothly and without complications.

Conclusion

Understanding SFDA requirements is essential for any brand aiming to enter the Saudi market. With proper classification, accurate documentation, and the right regulatory partner, companies can significantly reduce delays and secure fast, compliant access to one of the world’s most dynamic aesthetic markets.

If your brand needs support with registration or regulatory guidance in Saudi Arabia, Synners is ready to help.