SFDA Saudi Arabia Medical Device Registration
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.
Ensuring Compliance with SFDA Medical Device Regulations
Regulatory Authority
Pure Global can assist with Saudi Arabia's medical device registration, ensuring SFDA approval to sell in 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.
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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Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.