Medical Device Central Registration Regulation, Issue 1.0

The Medical Device Central Registration Regulation of the Gulf Health Council, issue 1.0 (2023) — the Council's central registration regulation for medical devices across the GCC. Thirty-three articles: the definition set (Article 1, which carries the device and IVD definitions and the terms the rest of the regulation uses), the scope and the products covered, the registration application and the documents it needs, the Council's review and the certificate it issues, the obligations of the manufacturer and the authorised representative, change notification, renewal, suspension and cancellation, the fees, and the final provisions. Article 33 states the regulation is published after approval by the ministries of health in the GCC and enters into force ninety days after publication, which is what makes it a Council instrument rather than a national one; it is recorded under Kuwait because this round assigns the Council's central registration instruments to its member markets, and the cover carries no date beyond the issue year 2023. The extract keeps all thirty-three article headings exactly as printed, including the colon the source uses after each article number.

Medical Device Central Registration Regulation, Issue 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.