22/11/2024

In the wake of the increasing technological development in the medical device sector, the Saudi Food and Drug Authority (SFDA) in October 2024 published an update of the MDS Guideline – G002, entitled ‘Guidance on Innovative Medical Devices’ (Version 3.0, 2024). This update is an opportunity to highlight the opportunities for those wishing to enter or strengthen their presence in the Saudi Arabian market, particularly with innovative devices.

The guidance aims to support innovators, developers, manufacturers and authorised representatives in obtaining marketing authorisation in the country for innovative Medical Devices through a simplified and accelerated regulatory pathway. The aim is to facilitate access in Saudi Arabia to advanced medical technologies that can improve the diagnosis, treatment and monitoring of patients while ensuring high standards of safety and effectiveness.

Criteria for the Designation of Innovative Medical Device

To be designated as ‘innovative’, a medical device must fulfil specific criteria:

  • Innovation characteristics: it must present technological attributes, indications of use or performance that have no equivalent in the local or global market.
  • Clinical benefits: must demonstrate a significant improvement over existing alternatives.

In addition to these criteria, SFDA may publish further specific requirements on its official website.

Of course, as with any other medical device, those designated as innovative must comply with the regulatory requirements in Saudi Arabia:  Medical Devices Act and its Implementing Regulations, Requirements for Marketing Authorisation of Medical Devices (MDS-REQ1), Essential Principles of Safety and Performance.

Review Process and Submission

The updated guideline describes in detail the review process and how to submit applications, which consists of two main steps:

  1. Preliminary application assessment (Submission): at this stage, free preliminary feedback based on SFDA expectations and regulatory requirements is provided to support applicants in preparing the technical file.
  2. Priority review of the marketing authorisation application: the application is given priority over the other applications in the queue, ensuring a faster but still comprehensive and detailed review, given the innovative nature of the device.

Applicants must present a clear justification demonstrating how the device meets the criteria of innovativeness. The SFDA may request additional information before finalising the designation and communicating the outcome of the application.

Opportunities in the Saudi Arabian Market

Saudi Arabia is a dynamic and constantly growing market for Medical Devices. This update is an incentive for companies to consider targeted strategies for their innovative devices while maintaining strong potential for more traditional devices.

For more information on how Medical Devices are marketed in Saudi Arabia, see the Country Overview available on Thema’s website.

>>> Thema’s experts are ready to support companies in defining effective regulatory strategies to access the Saudi Arabian market.

SOURCE:

https://www.sfda.gov.sa/sites/default/files/2024-10/%28MDS-G002%29EN.pdf