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Ensuring Compliance with SFDA Medical Device Regulations

With a robust economy and a population exceeding 35 million, Saudi Arabia represents a significant market for medical devices in the Middle East. The country's health care system is undergoing rapid expansion, marked by substantial investments in infrastructure and enhanced access to medical devices. The Saudi Food and Drug Authority (SFDA) plays a pivotal role in regulating and setting standards for medical devices, whether imported or locally manufactured. Saudi Arabia is renowned for its advanced healthcare services and boasts the largest medical device market in the MENA region.

Device Classification and Regulatory Pathways

Ensuring Compliance with SFDA Medical Device Regulations

Regulatory Authority

The SFDA is responsible for the regulation, oversight, and monitoring of medical devices in Saudi Arabia, ensuring they meet mandatory specifications. The Medical Device Marketing Authorization (MDMA) registration is a prerequisite for medical devices and IVDs to enter the Saudi market.

Classification

Medical devices in Saudi Arabia are categorized into Class A - Class C, based on the risk they pose. The classification of medical devices and IVDs is a crucial step in determining the regulatory pathway for SFDA registration. This process involves assessing the product's intended use and associated risks.

Key Requirements

Overseas manufacturers aiming to penetrate the Saudi market must:

  • Appoint a local Authorized Representative (AR) who will obtain the AR license essential for initiating the registration process.
  • Compile a comprehensive technical file and complete the MDMA application for submission to the SFDA.
How We Can Help

Tailored Support for Market Entry

Our expertise is geared towards simplifying your SFDA compliance and market entry:

  • Assistance with product classification and identification of the regulatory pathway.

  • Support in preparing the technical file and MDMA application for SFDA submission.

  • Acting as your Authorized Representative, managing the MDMA application process and ensuring adherence to post-market regulatory requirements.

We Provide Access To 28+ Markets Worldwide

Our team of experts and local representatives, supported by partnerships with hundreds of clinical labs and the extensive GRIP database for over 100 countries, accelerates product launches and ensures compliance across 28 countries.

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