Saudi Arabia – Authorized Representative

• The manufacturer or its authorized representative must submit the necessary documents demonstrating compliance with the Medical Device Regulations of at least one GHTF Founding Member jurisdiction for medical devices intended for the KSA market.
• Documents must be provided in English. If the original documents are in a language other than English, a summary or translation in English must be provided to the SFDA.
• Upon request from the SFDA, relevant parts of the document must be translated when a summary is provided.
• A Declaration of Conformity, written in English, must be provided, clearly identifying the medical devices to which the Declaration applies. It must confirm compliance with the regulatory requirements of the relevant GHTF Founding Member jurisdiction and the national provisions of this Interim Regulation.
• A copy of the medical device labeling, in English and/or Arabic, must be provided. The text of the labeling elements must consider the intended use of the devices and the qualifications of the users in the KSA.
• Information on any measures taken to accommodate specific environmental and/or conditions of use encountered in the KSA must be provided, if applicable.
• Measures to ensure correct storage, transportation, installation, and maintenance of medical devices in the KSA must be specified. Users must also be trained in their proper use.
• Undertake to report any relevant adverse event involving the medical device to the SFDA’s National Centre for Medical Device Reporting (NCMDR) as soon as it becomes aware of it.

The manufacturer must provide a copy of the written mandate that defines the designated responsibilities of the manufacturer’s authorized representative, if applicable.

The SFDA may request additional technical documentation before reaching its decision, providing justification for the request if necessary.