Medical Devices Registration Technical File Requirements, version 1.0

Medical Devices Registration Technical File Requirements, version 1.0, issued by the Gulf Health Council's medical-device registration committee. Its stated purpose is to clarify the technical requirements for medical device registration in order to obtain certification from the GCC Health Council, covering all medical devices including IVDs. After a purpose, a definitions list, a summary table that marks each requirement against device classes A to D, and ten numbered sections: device description, the information the manufacturer must supply, design and manufacturing information, the essential principles of safety and performance, risk management, product verification and validation, the post-market surveillance plan, the periodic safety update report, the quality management system, and submission through the Taawon portal. It is the technical-file detail beneath the Council's registration regulation, and it is what a Kuwaiti applicant's dossier is measured against. Two source artefacts are preserved: the cover's document-control header is Arabic and extracts with bidirectional and presentation-form characters around its labels, and the document's own contents page lists "Taawon Portal" as a top-level entry while the body numbers the same heading "10.", so the extract follows the body and the discrepancy is visible in the text. The cover's date field reads 1/23/2024, which is the date recorded here.

Medical Devices Registration Technical File Requirements, version 1.0 is the official identifier GHC uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.