Objectives:

The objectives of Executive Management for Pre-market Approval and Scientific Evaluation are to evaluate and verify the documents submitted for medical devices marketing authorization and intended to be marketed in Saudi Arabia, by ensuring compliance with SFDA- Medical Devices rules and regulations

Responsibilities:

Marketing authorization department:

  • Designate Conformity Assessment Bodies based on Medical Devices implementing rules under (MDIR).

  • Review and evaluating technical documents of the medical devices for the purpose of obtaining Marketing Authorization to ensure that the medical device complies with Medical Devices regulations and its implementing roles.

Medical devices scientific evaluation department:

  • Classify medical devices & In Vitro Diagnostic according to SFDA Medical Device Regulation.

  • Conduct scientific evaluation for exciting medical devices & In Vitro Diagnostic as well as conduct technical assessment for new technology.

  • Control and supervise clinical trials of medical devices & performance evaluation of In Vitro Diagnostics.

Standards and guidelines department:

  • Set guidance for special access medical device to illustrate procedures & requirements.

  • Study and recognize international standards relevant to medical devices with considerations on local requirements for Medical Devices and In Vitro Diagnostics.

  • Develop guidelines for medical devices manufacturers, authorized representatives, importers and distributors.

  • Develop specifications and requirements for advertisement of medical devices.

Quality and risk management:

Develop medical devices quality requirements and implement procedures for quality control as well as apply risk assessment for medical devices, In Vitro Diagnostics and non medical devices according international standards and the national regulations