Saudi Arabia Update – 2021
Welcome to the Arazy Group Medical Device Regulatory Update! Today’s update is from Saudi Arabia. Here is a quick summary of our update:
The first update is that a new risk classification system is set to eliminate the GHTF route to obtain MDMA. This update has been implemented since July 2nd, 2021.
The second update is the implementation of the new online registration system. This update has been implemented as of July 2nd, 2021.
The third update is the UDI system implementation. This update will be implemented by September 1st, 2022 for class B, C and D.
The last update is the fee for updating Medical Device Marketing Authorization applications. This update has been implemented as of January 13th, 2021.
Now let's talk about each update in detail.
In December 2019, through announcement 11, SFDA announced that the manufacturers may continue to use the GHTF route until March 31st, 2021.
However in July 2020, through announcement 1, SFDA allowed the manufacturer to use the GHTF route until January 1st, 2021.
In July 2021, the Saudi route was introduced. Now new applications must begin by using the Saudi route. The submission of a technical file is also required as part of the MDMA application. The GHTF route however, is still accepted for renewal and amendment applications. The MDMA certificate that was issued using the GHTF route will be valid until its expiration date.
By January 2022, all applications must use the Saudi route.
In October 2019, the new online registration system was introduced. Previously, the applicant was required to use a separate system to apply for MDMA, MDNR, and any other applications. In this new system, there will only be one system for multiple applications.
the manufacturer can still access the old system until January 2020. As of July 2021, the new online registration system has been fully implemented; therefore, all applications in the old system will be cancelled and all applicants must use the new system.
When the UDI system is implemented, the UDI information must first be indicated on the device's primary label. Secondly, it must be provided along with the MDMA application. And lastly, it must be submitted to the Saudi UDI database before the product is placed on the market.
The implementation of the UDI system will be done in phases. For class B, C, and D, the UDI must be implemented by September 1st, 2022. Whereas for class A, the UDI must be implemented by September 1st, 2023.
If you are looking to register your products in Saudi Arabia, consider LICENSALE, our Global MedTech Registration system for fast and easy market access.
The registration fee that is applicable for license amendment has been updated from previously being only one flat fee for all types of changes, into various fees depending on type of change.
The technical file that must be submitted during the MDMA application must contain at least the following information: device description and specification, label, instruction for use, promotional material, design and manufacturing information, essential principle, benefit risk analysis and risk management, product verification and validation, post market surveillance plan, periodic safety update report, and post market surveillance report.
That's it for our update today! If you have any comments or questions, please do not hesitate to email, or call us. Check the contact us page on our website for an Arazy Group office near you.
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