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Risk assessment of the consumable component of the product Additional documents required under the ECAS registration system (MOIAT / ESMA): Declaration of Conformity (DoC) Official statement affirming compliance with relevant UAE regulations ECAS or G-Mark Certificate One of these conformity certificates is required, depending on the product type Barcode / GTIN Mandatory for certain product categories during registration Label and Packaging Design Files Submitted for compliance review with UAE labeling and packaging requirements Bilingual Instructions or Label Content Arabic and English versions required for user manuals and safety information Product Images Clear photos showing the device, cartridge, and retail packaging Company Documents Valid trade license and manufacturing facility certificates
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