Table 1.

Comparison of regulatory frameworks for Saudi Arabia, UAE, and Qatar

GCC state	Basis of regulation	Regulatory body	Classification system used	Post-market surveillance requirements	Need for local representative
Saudi Arabia	Pre-existing approval in one of GHTF founding member countries	SFDA	According to pre-existing approval agency	Required to maintain a database of safety and performance data; Mechanism for corrective actions as necessary	Yes
UAE	Based on guideline from RDC; similar to EU but absolute requirement for both safety and effectiveness data	RDC under Ministry of Health	Own system, similar to EU: Class I=low risk, Class II=medium risk, non-implantable, Class III=medium risk, implantable, Class IV=high risk	Required to maintain a Medical Device Vigilance System database; Mechanism for corrective actions as necessary	Yes
Qatar	Pre-existing approval in one of GHTF founding member countries	Currently under MEC; Plans to change to Department of Pharmacy and Drug Control (SCH)	According to pre-existing approval agency	Not specified	Yes

Abbreviations: GHTF, Global Harmonization Task Force; SFDA, Saudi Food and Drug Administration; RDC, Registration and Drug Control Department; MEC, Ministry of Economy and Commerce; SCH, Supreme Council of Health; UAE, United Arab Emirates; GCC, Gulf Cooperation Council; EU, European Union.