Question 1

What is SFDA and why is it important for medical device companies?

Accepted Answer

SFDA (Saudi Food and Drug Authority) is Saudi Arabia's national regulatory authority for food, drugs, and medical devices. SFDA implements the Medical Devices and Supplies Regulation (Council of Ministers Resolution No. 337), commonly called the Medical Devices Law. All medical device companies must obtain SFDA Marketing Authorization (MDMA) and maintain compliance to sell products in Saudi Arabia's growing medical device market.

Question 2

What is the Technical File Assessment (TFA) route?

Accepted Answer

All devices requiring MDMA (Medical Device Marketing Authorization) must now follow the Technical File Assessment (TFA) route. Technical files from Global Harmonization Task Force (GHTF) member countries are no longer accepted as reference alone, though prior authorization in one GHTF market remains a prerequisite for MDMA certification. SFDA conducts full technical file review to ensure compliance with Saudi requirements.

Question 3

What is the Medical Devices Law and when was it implemented?

Accepted Answer

The Medical Devices and Supplies Regulation (Council of Ministers Resolution No. 337) is the primary legal framework governing medical devices in Saudi Arabia. The Implementing Regulation was introduced in 2021 to strengthen the regulatory framework, clarifying registration requirements, post-market surveillance, and enforcement mechanisms. This page tracks all updates to the Medical Devices Law and implementing regulations.

Question 4

How are medical devices classified in Saudi Arabia?

Accepted Answer

Saudi Arabia uses a risk-based classification system (Class A through D) aligned with international GHTF standards. Classification is based on intended use, invasiveness, duration of contact, and whether the device is active or implantable. All classes require pre-market MDMA approval prior to market entry, with Class D (highest risk) requiring the most extensive technical documentation and clinical evidence.

Question 5

What is an Authorized Agent and do foreign manufacturers need one?

Accepted Answer

An Authorized Agent (also called Saudi Agent or Local Representative) is a Saudi Arabia-based legal entity required for foreign medical device manufacturers. The Authorized Agent acts on behalf of the manufacturer in all regulatory interactions with SFDA, including MDMA applications, post-market surveillance, and compliance activities. All foreign companies must appoint an Authorized Agent to register and sell medical devices in Saudi Arabia.

Question 6

What GHTF countries does SFDA recognize for reference?

Accepted Answer

SFDA recognizes prior authorization from Global Harmonization Task Force (GHTF) member countries as a prerequisite for MDMA certification. Recognized authorities include: FDA (USA), EMA/CE Mark (Europe), Health Canada, TGA (Australia), PMDA (Japan), and others. While GHTF approval is required, SFDA still conducts full Technical File Assessment rather than relying solely on reference country reviews.

Question 7

How can I stay updated on SFDA regulatory changes?

Accepted Answer

This page automatically aggregates SFDA and Saudi Arabia medical device news from 7 premium regulatory intelligence sources daily, including RAPS, Pacific Bridge Medical, Emergo by UL, and others. Pure Global provides comprehensive regulatory support for Saudi Arabia market access.

SFDA News & Saudi Arabia Medical Device Regulatory Updates 2025

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