MRG Services in Saudi Arabia
The Saudi Food and Drug Authority (SFDA) was established by a Royal Decree in 2003 (1424H) under the Council of Ministers’ Resolution No. 1, dated 07/01/1424H (March 8, 2003).
🔹 It was established as an independent body reporting directly to the Council of Ministers.
🔹 The main goal was to ensure the safety, efficacy, and quality of food, drugs, and medical devices in the Kingdom of Saudi Arabia.
Saudi Food and Drug Authority (SFDA) Objectives,
- Setting and enforcing standards for food, drugs, medical devices, cosmetics, and tobacco products
- Licensing and auditing establishments and manufacturers
- Ensuring public health and safety in KSA through science-based regulatory practices
At Medical Regulation Gate (MRG), we proudly serve as your dedicated partner in navigating the complex and ever-evolving regulatory framework governed by the Saudi Food and Drug Authority (SFDA). With unmatched expertise across medical devices, pharmaceuticals, cosmetics, and non-medical imports, our services are tailored to ensure full compliance with SFDA requirements at every stage — from product classification, licensing, and registration to post-market surveillance, advertising approvals, and strategic market access. Whether you’re entering the Saudi market for the first time or managing a robust product portfolio, MRG empowers you with intelligent regulatory solutions that uphold safety, efficiency, and market success — always in alignment with the regulatory excellence of the Saudi Food and Drug Authority (SFDA).
1- Medical Devices
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)
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 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.
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-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.
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-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.
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-REQ1)
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-REQ11)
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. (saber.sa)
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.
2- Cosmetics
The Saudi Food and Drug Authority (SFDA) has progressively developed its Cosmetics Sector to ensure the safety, quality, and efficacy of cosmetic products available in Saudi Arabia.
The Saudi Food and Drug Authority (SFDA) issued the decree M/49 in 2015 that marked the official enactment of the “Cosmetic Products Law”, which formally established the regulatory framework for cosmetics under the Saudi Food and Drug Authority (SFDA).
🔹 It covers the manufacturing, importation, advertising, labeling, and marketing of cosmetic and personal care products in Saudi Arabia.
1. Cosmetics Registration Consultation
According to the Saudi Food and Drug Authority (SFDA), cosmetic products must be registered in the GHAD system and meet SFDA guidelines related to safety, labeling, and ingredient compliance. SFDA requires that cosmetics meet strict criteria to be marketed legally in Saudi Arabia, including proper documentation and adherence to safety assessments. (SFDA Cosmetics646)
Medical Regulation Gate (MRG) provides expert consultation to help manufacturers navigate the SFDA cosmetic registration process, ensuring that all regulatory requirements are met for smooth market entry.
2. Labeling & Packaging Compliance
As defined by the Saudi Food and Drug Authority (SFDA), all cosmetic products must have labels that comply with SFDA guidelines, which include product names, usage instructions, ingredients (INCI names), batch numbers, and manufacturing/expiry dates in both Arabic and English. (Guidance of Regulations and Requirements for Cosmetic Products notification)
Medical Regulation Gate (MRG) helps manufacturers align their product labels and packaging with SFDA guidelines to prevent non-compliance issues. This includes advising on proper labeling formats, ingredient transparency, and safety warnings as per SFDA regulations.
3. Ingredient Compliance & Safety Assessment
According to the Saudi Food and Drug Authority (SFDA), cosmetic manufacturers must use only ingredients that are listed in the SFDA Cosmetic Ingredients Database. All ingredients must meet SFDA’s safety assessment criteria, which are based on toxicological profiles and the restrictions of banned substances, preservatives, and colorants. (Guidance of Regulations and Requirements for Cosmetic Products notification)
Medical Regulation Gate (MRG) assists manufacturers in ensuring their products meet SFDA ingredient requirements. We provide safety assessments to guarantee that all ingredients used in cosmetic products comply with SFDA regulations.
4. Good Manufacturing Practices (GMP) Compliance
According to the Saudi Food and Drug Authority (SFDA), cosmetic manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure products are consistently produced according to quality standards. SFDA may also conduct audits to verify compliance. (Guide to Good Manufacturing Practice for Medicinal Products Version 4.3)
Medical Regulation Gate (MRG) provides assistance to manufacturers in establishing GMP procedures that meet SFDA guidelines, helping enhance product quality and ensuring market acceptance in Saudi Arabia.
3- Pharmaceuticals
The Saudi Food and Drug Authority (SFDA) has emerged as the supreme regulatory body overseeing pharmaceuticals in the Kingdom of Saudi Arabia. As part of its strategic evolution, the Pharmaceutical Sector within SFDA has played a pivotal role in elevating public health through the assurance of drug safety, efficacy, and quality.
By 2009, the SFDA assumed full regulatory authority over human pharmaceutical products, centralizing registration, licensing, importation, and post-market surveillance within a unified regulatory framework. The SFDA’s operational capability reached full maturity by 2010, setting a gold standard for drug evaluation and compliance in the region.
In a groundbreaking move, Royal Decree No. (M/108) issued on 22/08/1441H (April 15, 2020) established a modern and comprehensive pharmaceutical regulatory law, covering all aspects of pharmaceutical and herbal product management, licensing of establishments, and Good Manufacturing Practice (GMP) enforcement.
1. Pharmaceutical Registration Support
Saudi Food and Drug Authority (SFDA) defines pharmaceutical registration as the process of evaluating and approving medicinal products for sale in Saudi Arabia. It requires full documentation related to the product’s quality, safety, and efficacy. (Regulatory Framework for Drugs Approval Version 6.4)
Medical Regulation Gate (MRG) supports pharmaceutical companies in navigating SFDA’s registration process, ensuring compliance with all technical documentation and submission standards.
2. eCTD File Review & Validation
Saudi Food and Drug Authority (SFDA) requires that pharmaceutical applications be submitted in eCTD format. All eCTD submissions must adhere to SFDA’s technical specifications for validation. (Guidance For Submission)
Medical Regulation Gate (MRG) provides expert review and validation of eCTD submissions, ensuring compliance with SFDA standards.
3. Regulatory Strategy & Consultation
Saudi Food and Drug Authority (SFDA) emphasizes the need for a well-planned regulatory strategy for the successful market entry of pharmaceutical products. Pre-submission planning, lifecycle management, and alignment with SFDA requirements are essential for success.
Medical Regulation Gate (MRG) offers strategic consultation for pharmaceutical companies, guiding them through SFDA’s regulatory processes to ensure compliance and market success.
- Additional Regulatory Consulting Services
Quality Management System (QMS) Implementation
A Quality Management System (QMS) is a structured framework that documents the policies, processes, and procedures required for the design, production, distribution, and post-market monitoring of medical devices. The SFDA mandates that all manufacturers placing medical devices on the Saudi market comply with ISO 13485:2016 standards, as part of their regulatory conformity obligations under Saudi law.
At Medical Regulation Gate (MRG), we support manufacturers and medical device establishments in building, customizing, and implementing QMS frameworks that fully align with Saudi Food and Drug Authority (SFDA) requirements. From document control to internal audits, our QMS implementation programs ensure regulatory readiness, market acceptance, and long-term compliance with SFDA and ISO standards. As your trusted regulatory partner, MRG strengthens your foundation for safe and effective product delivery in Saudi Arabia.
Regulatory Due Diligence
Regulatory due diligence is the systematic process of evaluating the regulatory standing of products or companies during mergers, acquisitions, product licensing, or distribution agreements. As per SFDA expectations, this includes verifying marketing authorizations, establishment licenses, QMS certifications, adverse event history, and conformity documentation. Proper due diligence ensures informed decision-making and prevents regulatory liabilities.
Medical Regulation Gate (MRG) offers comprehensive regulatory due diligence services tailored for local and international stakeholders engaging in strategic business decisions. Whether you’re acquiring a medical device portfolio or entering a distribution agreement, MRG ensures full alignment with the Saudi Food and Drug Authority (SFDA) framework. Our evaluations reduce risk exposure and safeguard your investment by highlighting regulatory gaps before they become costly issues. With MRG, your strategic moves are supported by regulatory intelligence and SFDA-aligned precision.
