Ministry of Public Health (MOPH) - Qatar Medical Device Regulation

The Ministry of Public Health (MOPH) is the supreme authority for health in Qatar. Within its organizational structure, the Investment and Medical Devices Section, under the Department of Healthcare Professions (DHP), plays a critical role in the regulation and oversight of medical technology.

Regulatory Role and Role of the Section

The Investment and Medical Devices Section is responsible for ensuring that medical devices entering the Qatari market meet international safety and quality standards. Its core functions include:

• Market Regulation: Overseeing the registration and licensing of medical devices, particularly focusing on high-risk technologies such as Implantable Medical Devices (IMD).
• Technical Evaluation: Reviewing technical dossiers and clinical evidence based on reference market approvals from recognized jurisdictions (e.g., US FDA, EU CE Marking, and GHTF members).
• Investment Facilitation: Coordinating with stakeholders to streamline the procurement and investment in advanced medical technologies to enhance Qatar's healthcare infrastructure.
• Safety and Compliance: Ensuring that all devices are compliant with the State's quality requirements before they are authorized for clinical use or sale.

Key Regulatory Requirements

• Local Authorized Representative: Foreign manufacturers must appoint a locally registered Qatari agent (Authorized Representative) to manage registrations and act as a liaison with the MOPH.
• Implantable Devices Committee (IMO): All implantable devices must receive specific approval from the IMO Committee prior to import or use.
• Documentation: Submissions require ISO 13485 certification, a Certificate of Free Sale (CFS), and instructions for use in both English and Arabic.
• Import Permits: While some devices require full registration, others may be managed through a shipment-based import permit system overseen by the Pharmacy and Drug Control Department.

Classification

Qatar follows a risk-based classification system (Class I, II, III, and IV), aligning with global standards to ensure that evaluation processes are proportionate to the risk posed by the device.