MRG Services in Saudi Arabia

The Medical Devices Sector within the Saudi Food and Drug Authority (SFDA) was officially established in 2009 with the introduction of the Medical Devices Interim Regulation by decree No. (4-16-1439)

Medical Devices Sector at Saudi Food and Drug Authority plays a pivotal role ensuring safety, efficacy and performance of medical devices under a comprehensive legislation and regulation. Indeed, Saudi Medical Devices regulatory frame is aligned with international practice in terms of harmonization and convergence where it chaired the Global Harmonization Working Party (GHWP) and active member in many technical committees in International Medical Devices Regulators Forum (IMDRF) and International Organization for Standardization (ISO).

Medical Devices Regulation covers the entire lifecycle for medical devices starting from the idea, concept, manufacturing process and ending by reaching the product to end users in addition to monitoring the performance and safe use of medical devices.

Services of Medical Regulation Gate (MRG)

According to the Saudi Food and Drug Authority (SFDA), an Authorized Representative (AR) is a Saudi establishment licensed by SFDA, appointed by a foreign manufacturer to legally represent them in Saudi Arabia for regulatory matters related to medical devices. ( MDS-G5 )

At Medical Regulation Gate (MRG) , we are licensed as a consultation company (License Number: CO-2023-FO-0022) to act as Manufacturer’s Authorized Representative (AR) in Kingdom of Saudi Arabia (KSA). Our team ensures that your products meet all SFDA regulatory requirements, serving as the official point of contact between your company and the SFDA.

As per the Saudi Food and Drug Authority (SFDA) , the process of Manufacturing Site Registration involves registering the physical location of a medical device manufacturer with SFDA through the Authorized Representative (AR) portal to ensure compliance with regulatory standards. This process is vital to obtain the Authorized Representative License (ARL) to facilitate smooth regulatory approval and market entry. ( MDS-REQ9 )

At Medical Regulation Gate (MRG) , we assist in registering the legal manufacturer, ensuring they meet SFDA guidelines for manufacturing and distribution in Saudi Arabia.

According to the Saudi Food and Drug Authority (SFDA) , a Medical Device Establishment License (MDEL) is a license issued to establishments involved in the importation, distribution, or warehousing of medical devices in Saudi Arabia. It confirms that the establishment adheres to SFDA’s regulatory and quality requirements. ( MDS-REQ9 )

Medical Regulation Gate (MRG) supports local companies in obtaining the MDEL from the SFDA, allowing them to legally distribute and market medical devices within Saudi Arabia. We navigate the regulatory complexities to ensure a smooth application and approval process.

The Saudi Food and Drug Authority (SFDA) provides specific guidelines and regulations that medical device establishments must follow to meet safety, efficacy, and performance requirements. Regulatory consultation encompasses fulfilling obligations under the SFDA's Medical Device Interim Regulation , including classification, technical documentation, and vigilance. ( MDS-G5 )

At Medical Regulation Gate (MRG) , we offer expert regulatory guidance to help you meet all SFDA requirements, ensuring compliance with Saudi regulations and avoiding any potential delays or rejections.

Continuous professional development is essential to staying compliant with the SFDA’s evolving regulations. The Saudi Food and Drug Authority (SFDA) highlights the importance of remaining updated on new regulatory changes to maintain compliance in Saudi Arabia’s dynamic regulatory environment.

Medical Regulation Gate (MRG) provides ongoing updates and training to our clients on the latest SFDA regulations and guidelines. This ensures your team remains well-informed and prepared to meet SFDA requirements at all stages of the product lifecycle.

The Saudi Food and Drug Authority (SFDA) recognizes devices that have already been approved by reference countries (such as GHTF members), streamlining registration through the MDMA-1 pathway, based on the conformity assessment of these countries. ( MDS-REQ1)

At Medical Regulation Gate (MRG) , we handle the MDMA-1/GHTF application process for your devices, including renewals, technical file preparation, and ensuring compliance with SFDA’s requirements for marketing authorization in Saudi Arabia.

According to the Saudi Food and Drug Authority (SFDA) , MDMA-2 applies to medical devices not covered under MDMA-1 . It requires full technical documentation assessment and conformity evaluation before the product can be marketed in Saudi Arabia. ( MDS-REQ1)

Medical Regulation Gate (MRG) manages the registration, renewal, and updates of MDMA-2 for medical devices, facilitating seamless regulatory approval with the SFDA. Our team ensures that all required documentation and compliance standards are met.