Start your UDI listing with the Saudi FDA now

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    UDI system (Ramz) aims to document unique devices codes for medical devices based on accredited international standards, with the purpose to allow all stakeholders to identify medical devices information through the unique device identification code that is registered on the system.

    Manufacturers and their authorized representatives are directly responsible to provide all data of unique device identification codes for their medical devices and modify them according to the compliance timeframe indicated by the Saudi FDA.

    Compliance Timeframe 

    2UDI-timeframe-SFDA--uai-1032x461

    Regulations: According to the Saudi Medical Device Low, Article 10, Clause 10/12, Section 3.c

    Guidance on Requirements for Unique Device Identification (UDI) for Medical Devices. 

    The Issuing Agencies: GS1, HIBCC, ICCBBA.

    Questions & Answers

    Saudi-DI can be present in multiple levels of packaging for the product, starting from the lowest level of packaging (for example, pouch or plastic bag) to the highest level of packaging, such as shipping boxes.

    No fees are required by the Saudi FDA for Saudi-DI listing. 

    According to the compliance timeline, your product will not be able to enter the Saudi market without the Saudi-DI, thus, preventing its sales and trading in the Saudi market. 

    The Saudi FDA doesn’t approve the information entered for the Saudi-DI; the system will only list the submitted information with no approval required; accordingly, the information listed has to be accurate to ensure no issue will arise when the shipments arrive at the Saudi customs.

     

    • Fast listing
    • Accurate listing
    • Guarantee a smooth importation of your shipments with no issues