To ensure the safe and efficient marketing of medical devices in the Kingdom of Saudi Arabia, manufacturers and importers are required to apply for a Medical Device Marketing Authorization (MDMA) certificate from the Saudi Food and Drug Authority (SFDA) before starting importation and distribution. The SFDA plays a crucial role as the regulatory authority responsible for ensuring the safety, effectiveness, and quality of medical devices in the market, relying on international standards to evaluate and register these devices.
In this article, we will discuss in detail the steps for registering a medical device in Saudi Arabia and review the technical and administrative requirements for registering medical supplies and equipment, including post-market surveillance conducted by the SFDA to ensure continued compliance with the established standards.
Step 1: Licensing:
Before beginning the registration process, companies must obtain a facility license from the SFDA, granting them the right to import and market their products in the Saudi market. This license ensures that the company adheres to the required safety and quality standards.
Step 2: Legal Representative Registration
Before registering a medical device with the SFDA, it is essential for manufacturers of medical devices to appoint an authorized legal representative in the Kingdom of Saudi Arabia. This representative holds significant responsibility, being accountable to the SFDA for ensuring the safety, effectiveness, and quality of the medical devices marketed. They are also responsible for ensuring compliance with the regulations for marketing medical devices and reporting any usage errors or potential risks related to the devices.
To appoint the legal representative, manufacturers can choose their local distributor as their representative or opt for an independent consulting firm with expertise and specialization in regulatory compliance.
Step 3: Medical Device Registration
After obtaining the facility license, companies can begin the process of registering their medical products with the SFDA. This registration requires providing detailed information about each product, including ingredients, intended uses, and proof of safety and efficacy.
Step 4: Requirements and Standards
Registered products must comply with the standards and regulations set by the medical devices and supplies system, which ensures that the products meet health and quality specifications. These products must undergo rigorous testing to confirm their safety and efficacy before entering the market.
Step 5: Monitoring and Tracking
After product registration, the SFDA conducts periodic surveillance to ensure continuous adherence to approved standards, tracking batches and reviewing complaints and reports from consumers and professionals.
Conclusion
Registering a medical device with the SFDA is not just a regulatory procedure but a critical step in ensuring the availability of safe and effective products in the Kingdom of Saudi Arabia. It reflects the company’s commitment to quality and responsibility toward customer health and safety.
Ghad Electronic Platform (Medical Device Registration System)
Within the Saudi market, the Ghad system (ghad) stands out as a comprehensive electronic platform dedicated to registering and managing medical devices and supplies, from obtaining work licenses to distribution.
This system enables Saudi companies and manufacturers to obtain the necessary licenses for activities related to the trade, import, and distribution of medical devices and supplies, facilitating the efficient and effective entry of these products into the Saudi market.
The Ghad system is a strategic step toward organizing and simplifying the trade of medical devices and supplies within the Kingdom, as it requires manufacturers and importers to register in this system to ensure their products comply with the defined standards and regulations.
Through this platform, companies can not only register their products but also renew licenses, apply for changes and updates needed for their products, ensuring continuous compliance with the applicable laws and standards. The SFDA plays a key role in this process, reflecting its commitment to ensuring the quality and safety of medical devices and supplies traded in the Saudi market.
In conclusion, the Ghad system represents a vital meeting point between regulatory authorities and commercial entities, providing a clear legal framework for marketing and distributing medical devices and supplies in Saudi Arabia, ensuring consumer expectations of quality and safety are met.
Medical Device Registration
To register medical devices in Saudi Arabia, companies must apply for a Medical Device Marketing Authorization (MDMA) from the Saudi Food and Drug Authority. This procedure is mandatory for all medical devices, regardless of their risk level. Notably, applying for marketing authorization requires first obtaining a certificate of legal representation, confirming the appointment of an authorized legal representative in the Kingdom, before submitting the official application for medical device marketing authorization.
Medical Device Registration Requirements
The registration requirements for medical devices depend on the type of device, its risk level, and intended use. Compliance with these requirements does not automatically guarantee approval from the SFDA. Inaccurate submission of files or unscientific responses to the SFDA’s inquiries may lead to registration rejection, even for globally recognized products. This means that registration fees paid to the SFDA may be lost. Below is a list of the essential requirements for medical device registration:
- Product Card: A detailed document displaying information about the medical device.
- Conformity Declaration: From the manufacturer, confirming the device complies with legal and technical standards.
- Instructions for Use (IFU): A user manual providing instructions on how to safely use the device.
- Brochures/Marketing Materials: Providing information about the device.
- Registered Authority Name and Number: Registration details with other regulatory bodies.
- CE Certificate: Proving the device complies with EU safety, health, and environmental requirements.
- Quality Management System (QMS): Must be compliant with ISO 13485 standards.
- Audit Report: Includes audit results confirming the company’s adherence to quality standards.
- Specific Data Forms: From the SFDA.
- Environmental Statement and Marketing Authorization Statement.
Technical File for Medical Device
A technical file for a medical device is a comprehensive document containing all detailed information about the device. It includes:
- Table of Contents: Provides a quick overview of the technical file’s content.
- Clinical Evaluation Report (CER): Summarizes the results of the device’s clinical evaluation, including a review of relevant medical literature and clinical studies.
- Biological Evaluation Reports: A thorough analysis of the device’s biological impact, including biocompatibility test results.
- Post-Market Surveillance Plan and Report (PMS): Documents activities and results related to monitoring the device after marketing.
- Post-Market Clinical Follow-Up (PMCF) Plan and Report: Provides analysis of clinical data collected after the device is launched in the market.
- Risk Management File (RMF): Identifies potential risks associated with the device and outlines mitigation measures.
- Risk Classification Standards/Rules and Rationale: Highlights how the device is classified based on the identified risk levels and the rationale for this classification.
The SFDA may request additional information or documents to complete the registration process, depending on the evaluation of the technical file provided.
Success in registering medical devices with the SFDA requires transparency and accuracy in submitting the necessary files and documents. A vital factor is the ability to provide scientifically sound and documented responses to the SFDA’s inquiries. This reflects the company’s understanding of regulatory requirements and the quality and safety of the medical device presented.
Therefore, transparency in the process, along with accuracy and attention to detail in preparing and submitting documents, forms the foundation for successful and effective registration of medical devices. Companies that follow these standards demonstrate their commitment to international quality and safety standards, facilitating the review and evaluation process by the SFDA and reducing the likelihood of rejection or repeated requests for additional data or clarification.
Services of Medical Support Logistics Company
Medical Support Logistics Company stands out as a leader in registering medical products, devices, and supplies with the Saudi Food and Drug Authority (SFDA). The company’s registration team, made up of highly experienced professionals holding pharmacy degrees, provides exceptional support in navigating strict regulatory requirements, ensuring compliance with health and legal standards.
Medical Support Company does not limit its services to registration alone but extends to offering diverse storage solutions. The company provides pallet storage or self-storage within SFDA-licensed facilities, catering to the needs of various medical traders and companies. Additionally, Medical Support Company offers specialized services for e-commerce stores, including automated integration with platforms like Salla and Zed, making it easier for clients to manage inventory and orders efficiently.
The storage contracts provided by Medical Support Company perfectly meet traders’ needs, offering flexibility and security in logistics services. With its presence in key locations like Riyadh, Jeddah, Dammam, and Khobar, the company ensures comprehensive coverage and the ability to deliver to all regions of the Kingdom, enhancing the efficiency and effectiveness of the medical product supply chain.
Ultimately, Medical Support Company stands as a strategic partner in the healthcare sector, offering clients high-level registration and storage services with professionalism and compliance, while providing logistics solutions that are accurate and efficient to support their diverse business needs in the Saudi market.
