KSA regulatory update

In this blog we will go into more detail on the Medical Device Marketing Authorization (MDMA) and the role of the Authorized Representative in KSA. Contact us if you need regulatory support for KSA market entry. 

Contact Us Medical Device Marketing Authorization (MDMA)

The Saudi Food and Drug Authority (SFDA) sets the regulatory standards for medical devices and IVD in KSA. The MDMA is an authorization system ensuring that these regulatory standards are met and that the devices meet national and international safety, quality, and performance standards. MDMA is the approval given by the SFDA to both manufacturers and local distributors to enter the market and sell their medical devices and IVD’s. Both manufacturers and distributors must understand and comply with MDMA regulations. In case MDMA standards are not met, the application may be delayed, rejected, or even remitted.

Dependent on the classification of the device, thorough documentation is required at each step of the process in areas like clinical evaluations, risk management, and labelling. All necessary information must be compiled and submitted to SFDA by manufacturers or their local Authorized Representatives (AR). 

The MDMA Process has a few key components: 

1. Device Classification (classification is according to its risk level and regulations and documentation required are based on the classification);

2. Technical Documentation (to demonstrate that the device meets essential safety and performance requirements. For high-risk devices, this includes product descriptions, risk assessments, clinical evaluations, and test reports);

3. Labelling Requirements (in addition to CE or IVD symbols, the label must include details about the device, instructions for use, and warnings);

4. Clinical Evaluation and Performance Evaluation (clinical evaluation report submission is mandatory for most devices to ensure that the device is safe for its intended use and that it performs as intended). Analytical and clinical performance standards must be demonstrated for IVD devices through performance evaluation);

5. Licensed Representative (LR) (manufacturers from outside of Saudi Arabia need to appoint an AR to represent them as required by the SFDA. The AR plays an important role in ensuring compliance, facilitating device registration and monitoring post-market activities. In MDMA applications, the AR ensures that all submitted documentation meets SFDA standards, which is of particular importance).
   

Post-Market Surveillance

After a device has been approved, post-market surveillance has to be conducted. Both adverse events and any change in the device's performance or safety profile should be reported to the SFDA. The manufacturer has an obligation to monitor the device's use to ensure that risks are communicated timely and managed well.

The Medical Device Marketing Authorization (MDMA) process protects patients, healthcare providers, and the public. Medical devices available in Saudi Arabia must not only be effective, but also meet the highest safety standards. Compliance with SFDA regulations contributes to a healthcare system that prioritizes innovation and patient safety. A regulatory expert or AR can guide companies efficiently through the process by working closely with them.

The Authorized Representative (AR) role in Medical Device Registration

An Authorized Representative (AR) represents the foreign manufacturer in KSA. In addition to ensuring that the manufacturer's medical devices comply with local regulatory requirements, the AR facilitates communication between the manufacturer and local regulatory authorities. Medical device registrations are strictly regulated by the SFDA, so having an AR that is knowledgeable on the local regulatory environment and compliance rules is essential (including how to navigate the SFDA’s electronic systems for product registration and renewal).

The main responsibilities of an AR are:

1. Compliance with Local Regulations (the AR works closely with the Saudi Food and Drug Authority (SFDA) to ensure that all regulations are followed);

2. Documentation and Labelling (the AR ensures that all necessary documentation, such as technical files, declarations of conformity and product labels meet local requirements);

3. Communication with Regulatory Bodies (as the manufacturer's representative, the AR communicates with regulatory authorities on behalf of the manufacturer on questions related to for instance the product registration and registration renewal);

4. Surveillance and Vigilance After Market (the AR monitors the performance of the medical device and IVD and reports any adverse events or product issues to the  appropriate authorities);

5. Facilitating Product Registration (the AR is responsible for facilitating the product registration process, including assisting manufacturers with applications for MDMA).
   

Appointing an AR in KSA

Several steps need to be taken to appoint an AR in Saudi Arabia:

1. Formal Agreement (an official agreement between the foreign manufacturer and the AR needs to be established and authenticated by relevant authorities);

2. Registration with SFDA (the AR must register with the SFDA, creating an account in their Unified Electronic System (GHAD) to manage applications and communications);

3. Compliance with Quality Standards (ensure adherence to the SFDA's Quality Management System requirements, such as SFDA MD/GSO, ISO 13485:2016);

4. License Application (submit a license application to the SFDA and pay the fees);

5. Ongoing Obligations (maintain compliance through regular renewals and updates, as well as fulfilling post-market surveillance responsibilities).
   

The Authorized Representative (AR) is crucial to ensuring that medical devices meet regulatory requirements in foreign markets. To ensure a smooth product launch and ongoing compliance with local regulations, manufacturers should hire a capable AR that facilitates communication, ensures proper documentation and handles post-market activities. Manufacturers can navigate regulatory challenges and successfully introduce their products to the Saudi market by understanding and leveraging AR expertise.

Gateway MedTech can act as your local AR through our local expert partner. Contact us if you need support.