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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 ARs are directly responsible to provide all data of UDI codes for their medical devices and modify them according to the compliance timeframe indicated by the Saudi FDA.

• ‍Guidance on Requirements for Unique Device Identification (UDI) for Medical Devices
• Regulations According to the Saudi Medical Device Low, Article 10, Clause 10/12, Section 3.c

Points to remember before filling the form:-

• You MUST be an Authorized Representation with Bio-Standards.
• You MUST have a a valid MDMA registration.
• UDI MUST be issued by the following agencies - GS1, HIBCC & ICCBBA

^{**Incase of none of the above reach out to our customer care at info@bio-standards.com for a complimentary consultation.}