Objectives:
The executive management of pre-marketing and scientific evaluation aims to evaluate and conform the technical documents provided for the purpose of obtaining permission to market medical devices and products for marketing and use in Saudi Arabia by ensuring compliance with all the conditions and requirements stipulated in the regulation of medical devices and products.
Responsibilities:
-
Marketing Authorization Department:
- Evaluation and selection of conformity verification offices based on procedural evidence for medical devices and products.
- Evaluation and review of technical documents for applications to authorize the marketing of medical devices and products within the Kingdom of Saudi Arabia by making sure that they comply with the regulation of medical devices and products and their special requirements.
-
Department of Scientific Assessment:
- Classification of medical devices, products and laboratory reagents based on the regulation of medical devices in the SFDA.
- Scientific evaluation of medical devices, laboratory reagents and technical evaluation of modern techniques.
- Supervision and follow-up in the field of practical tests of medical devices and performance evaluation of laboratory reagents
-
Management of specifications and guides:
- Study and review the international standards and standards for medical devices and products and their suitability to local requirements for medical devices and products.
- Develop guidelines for manufacturers, legal representatives, importers and distributors, relating to regulations and requirements for medical devices and products.
- Develop the requirements and requirements for medical devices and products.
- The work of the manual on medical devices and products excluded from the marketing authorization system and the definition of its requirements and procedures.
-
Quality and Risk Management:
- Develop quality requirements and procedures on medical devices and products, and activate risk management procedures, based on international standards and local regulations of the regulation of medical devices and products
Important Links
الهيئة السعودية للمواصفات والمقاييس والجودة (SASO)
هيئة التقييس لدول مجلس التعاون لدول الخليج العربية (GSO)
اللجنة الأوروبية للتقييس (CEN)
المنظمة الدولية للتقييس (ISO)
الهيئة الدولية الكهروتقنية (IEC)
الجمعية العلمية الأمريكية للأجهزة الطبية (AAMI)
