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Classification support
Review of intended use, claims and product description to support a consistent classification discussion.
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Industry focus
Assistance with classification questions, registration pathways, technical documentation, manufacturer papers, label review, submission support, renewal and regulatory maintenance.
Category perspective
Medical device work focuses on how the product is described, classified and documented for the intended UAE or GCC market. MEPA supports manufacturers and local partners with pathway planning, file organisation and labelling review. It does not act as a notified body or issue device certificates.
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Review of intended use, claims and product description to support a consistent classification discussion.
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Mapping of the likely route for the device type and the documents commonly requested.
03
Organisation of existing technical files, instructions for use and supporting evidence supplied by the manufacturer.
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Checks on device labelling, IFU content and artwork consistency.
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Support compiling application materials and responding to questions during review.
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Help identifying quality and manufacturing papers typically requested from the legal manufacturer.
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Practical sequencing for first introduction of a device into a defined GCC market.
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Support for ongoing listing or registration maintenance, including change documentation.
Questions, answered
No. Device certificates, conformity assessment and notified-body functions are performed by the relevant independent or competent organisations. MEPA provides consultancy support only.
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