Post-market surveillance (PMS) is vital to ensure medical devices remain safe and effective after entering the market. In the Gulf Cooperation Council (GCC) countries—Saudi Arabia, UAE, Qatar, Oman, Bahrain, and Kuwait—specific regulations govern PMS practices. Post-market surveillance in the GCC is crucial for maintaining the safety and effectiveness of medical devices. Each country has specific regulations that manufacturers must follow, such as the Saudi Medical Device Interim Regulation (2021) in Saudi Arabia, UAE Federal Law No. 4 (2015) in the UAE, and Qatar’s Medical Device Regulations (2017). Compliance with these regulations helps safeguard public health and ensures continuous device efficacy.
Here’s an overview of each country’s requirements:
Saudi Arabia (SFDA)
The Saudi Food and Drug Authority (SFDA) regulates medical devices under the Saudi Medical Device Interim Regulation (2021), effective from March 2021, and the Medical Device Law (Article 23). PMS requirements include:
- Adverse Event Reporting: Manufacturers must report adverse events within 10-15 days.
- Periodic Safety Update Reports (PSURs): Manufacturers must submit PSURs regularly, as required by the Saudi Medical Device Regulation.
- Field Safety Corrective Actions (FSCA): Manufacturers must notify the SFDA of any corrective actions if issues arise.
United Arab Emirates (MOHAP)
The Ministry of Health and Prevention (MOHAP) governs medical devices under UAE Federal Law No. 4 (2015), with implementing Medical Device Guidelines (2018). PMS requirements include:
- Adverse Event Reporting: Must be reported within 10 days.
- Recalls and Corrective Actions: Timely communication of recalls and actions is mandated.
Qatar (QCHP)
In Qatar, the Qatar Council for Healthcare Practitioners (QCHP) regulates PMS under the Medical Device Regulations (2017), which came into effect in January 2017. PMS requirements are:
- Incident Reporting: Adverse events must be reported within specified timelines.
- Ongoing Risk Management: Manufacturers must monitor devices continuously for safety
Oman (MOH)
The Oman Ministry of Health (MOH) oversees medical devices under the Medical Device Regulations (2019), implemented in January 2019. Key PMS practices include:
- Post-Market Data Collection: Ongoing data collection on device safety and performance.
- Regulatory Compliance: Devices must comply with both local and international standards.
Bahrain (NHRA)
In Bahrain, the National Health Regulatory Authority (NHRA) regulates medical devices under the Bahrain Medical Devices Regulations (2018), effective from October 2018. PMS requirements include:
- Adverse Event Reporting: Prompt reporting of any incidents.
- Vigilance and Risk Evaluation: Continuous risk assessment to identify and address safety concerns.
Kuwait (MOH)
In Kuwait, the Ministry of Health (MOH) governs medical devices under the Medical Device Law (2018), which was implemented in January 2018. PMS practices include:
- Post-Market Monitoring: Continuous monitoring for safety and efficacy of devices.
- Safety Audits: Regular safety audits to ensure compliance with regulations.
Regulatory Framework for Post-Market Surveillance of medical Devicesin GCC Countries
