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.
1. Authorized Representative Services
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 Regulationa 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.
2. Manufacturing Site Registration
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.
3. Medical Device Establishment License (MDEL)
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.
4. Regulatory Guidance & Compliance
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.
5. Regulatory Updates & Training
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.
6. Medical Device Marketing Authorization (MDMA-1/GHTF)
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–REQ 1
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.
7. Medical Device Marketing Authorization (MDMA-2)
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–REQ 1
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.
8. Regulatory Documentation Review
The Saudi Food and Drug Authority (SFDA) requires comprehensive reviews of medical device documentation, such as Quality Management Systems (QMS), technical files, labeling, and clinical evaluations, to ensure compliance with their regulatory standards. MDS–REQ 1
At Medical Regulation Gate (MRG), we offer thorough regulatory documentation reviews, identifying any gaps and ensuring that all documentation meets the SFDA’s requirements. This minimizes the risk of rejections or delays in the approval process.
9. SFDA Liaison & Communication
Effective communication with the Saudi Food and Drug Authority (SFDA) is key to maintaining regulatory compliance. As per the SFDA’s guidelines, it is essential for medical device manufacturers to address inquiries, updates, and significant changes promptly to remain in good standing.
Medical Regulation Gate (MRG) facilitates ongoing communication with the SFDA on your behalf, ensuring that all inquiries are addressed, necessary updates are submitted, and any changes are effectively communicated to the regulatory authorities.
10. Post-Market Surveillance & NCMDR Compliance
The Saudi Food and Drug Authority (SFDA) mandates post-market surveillance as a critical activity for monitoring medical device performance, addressing adverse events, and ensuring product safety after market approval. This includes managing Medical Device Reports (MDR), safety alerts, and recalls through the National Center for Medical Device Reporting (NCMDR). MDS_REQ 11
Medical Regulation Gate (MRG) aids with post-market surveillance activities, ensuring your products remain compliant with SFDA requirements. We also help manage your reports to the NCMDR, ensuring the safety and effectiveness of your products post-approval.
11. Product Classification Services
The Saudi Food and Drug Authority (SFDA) classifies medical devices based on their intended use and risk level. This classification process determines which regulatory requirements the product must meet. Saudi FDA Products Classification Guidance V8.0
Medical Regulation Gate (MRG) assesses and submits product classification requests to the SFDA, helping you determine the regulatory pathway for your device and ensuring compliance with Saudi regulations.
12. Unique Device Identification (UDI) Submission
The Saudi Food and Drug Authority (SFDA) requires the submission of Unique Device Identification (UDI) data to their system to ensure proper tracking of medical devices and compliance with post-market surveillance regulations. MDS-REQ7
At Medical Regulation Gate (MRG), we assist with the UDI submission process, ensuring that your devices are properly tracked in the SFDA’s system and fully compliant with Saudi regulations.
13. Advertising Request
According to the SFDA’s advertising regulations, all medical device advertising materials must be approved before distribution. The advertising content must be truthful, non-misleading, and comply with the guidelines set by the SFDA. MDS-REQ8
Medical Regulation Gate (MRG) provides comprehensive support for obtaining SFDA approval for your advertising materials, ensuring that all promotional content, whether online or offline—meets SFDA guidelines and regulatory requirements.
14. Importation & SABER Compliance
The Saudi Food and Drug Authority (SFDA), in collaboration with the Saudi Standards, Metrology, and Quality Organization (SASO), governs the importation of medical devices through the SABER platform. This system ensures that medical products meet SFDA and SASO regulations before they are imported into Saudi Arabia.
Medical Regulation Gate (MRG) guides you through the SABER system to ensure that your products meet all regulatory requirements for importation, from obtaining the Product Certificate of Conformity (PCoC) to ensuring SFDA approval before shipment.