The European Commission’s Commission Recommendation Document (EU) 2013/172 and several related regulatory documents get the attention to the medical devices reporting system. The Kingdom of Saudi Arabia is one of the countries that has taken action. The Saudi Food and Drug Authority (SFDA) manages and monitors all the processes and has developed a database named Saudi-DI. The database was introduced and became effective on 1st October 2020.
You can find our clients’ most common Unique Device Identification (UDI) questions, and their answers, below.
- When will the obligation start?
The timeline for placing labels on medical device has changed since the European Commission’s announcement, and is currently as follows:
- September 2023 for class B, C (medium risk), and D devices (high risk)
- September 2024 for class A devices (low risk)
2. Who is responsible?
All medical devices that enter the Saudi Arabian market fall under the scope of the regulation. There are no exemptions from the UDI regulation. All devices must be reported and labeled before being placed on the market.
As mentioned above, if the standards announced by the general European Commission are used, there may be minor differences.
3. Which types of devices must be registered?
SFDA has divided the implementation of the UDI into two main phases. The first phase will start in September 2023 for class D, C, and B (high- and medium-risk medical devices).
Devices classified as class D (high risk) have a major impact on sustaining or recovering human life, such as brain spatulas and pacemakers. Class-B and C devices have less impact on sustaining or recovering patients’ lives relative to class-D devices.
The second phase will begin in September 2024 for class-A devices (low risk).
Medical devices that are classified in class A have the lowest impact on improving and maintaining human life.
4. What are the technical requirements of the declaration?
The required information must be reported to the Saudi-DI database in XML format before submission authorization is required. Medical device suppliers, importers, authorized representatives, and third parties must be registered with the database and each application must be reviewed by the SFDA.
5. What are the advantages of using UDI on medical devices?
Most governments wanted to integrate electronic registration of medical devices to their systems. The many benefits of this development include:
- Reporting problems related to devices
- Increasing efficiency in production, storage, and distribution
- Complying with national and international regulations and standards
- Making it easier to make recalls from the market for repair, control, adjustment operations
- Preventing incidents associated with misuse
- Facilitating stock tracking and order arrangements
- Improved reporting and statistics
- Helping to combat fraud
For more information about the process and our related solutions, please contact us at email@example.com.