An easy guide on how to meet SFDA regulations for a Class 1 IVD medical device.

January 6, 2023 by
Afiyatech, Advisor

If you are planning to bring a Class 1 in vitro diagnostic (IVD) medical device to market in Saudi Arabia, it is important to understand the regulatory requirements that apply to your product. In this article, we will provide an overview of the regulatory process for Class 1 IVD medical devices in Saudi Arabia, including the requirements for pre-market review and approval, labeling and instructions for use, and post-market surveillance.

Pre-Market Review and Approval for Class 1 IVD medical device

Before a Class 1 IVD medical device can be sold in Saudi Arabia, it must undergo a pre-market review and approval process. This process is designed to ensure that the device meets the quality, safety, and efficacy standards established by the Saudi Food & Drug Authority (SFDA).

To begin the pre-market review and approval process, you will need to submit an application to the SFDA. 

This application should include the following information:

  • A detailed description of your product, including its intended use, intended population, and any special features or characteristics.
  • A detailed description of the manufacturing process for your product, including information about the materials and components used, the production process, and any quality control measures in place.
  • Clinical data demonstrating the safety and efficacy of your product. This may include data from clinical trials or other studies.
  • A risk assessment of your product, including a description of any potential risks or side effects.
  • Labeling and instructions for use for your product.

The SFDA will review your application and may request additional information or clarification as needed. Once the review process is complete, the SFDA will either approve or reject your application. If your application is approved, you will be granted a marketing authorization for your product.

Labeling and Instructions for Use

Once your Class 1 IVD medical device has been granted a marketing authorization, you will need to ensure that it is properly labeled and that instructions for use are provided. These materials should be written in clear, easy-to-understand language and should include the following information:

  • A clear and concise description of the device and its intended use.
  • A list of the device's performance characteristics, including its accuracy and precision.
  • A description of any potential risks or side effects associated with the use of the device.
  • Detailed instructions for use, including information about how to prepare and use the device, how to interpret the results, and how to properly maintain and store the device. 

Post-Market Surveillance

Once your Class 1 IVD medical device is on the market, the SFDA will continue to monitor its performance through a system of post-market surveillance. This includes collecting and analyzing data on the device's safety and effectiveness, as well as monitoring reports of adverse events or other issues related to the device.

If the SFDA determines that your device poses a risk to public health or that it is not performing as intended, it may take a number of actions to address the issue. These actions may include issuing a recall of the device, requiring a label change or additional warning, or suspending or revoking the device's marketing authorization.

It is important to maintain a strong relationship with the SFDA and to be proactive in addressing any issues that may arise. This may include conducting additional testing or clinical studies, or implementing changes to your manufacturing process.

Ensure your Company Maintaining the Roles for a Class 1 IVD Medical Device

Meeting the regulatory requirements for a Class 1 IVD medical device in Saudi Arabia requires careful planning and attention to detail. By following the steps outlined above and working closely with the SFDA, you can help to ensure that your device meets the necessary standards and can be brought to market successfully. 

By meeting these requirements, you can also help to protect the health and well-being of patients in Saudi Arabia and contribute to the overall quality of the healthcare system in the country.

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