GCC Harmonisation
What is the GCC?
The Gulf Cooperation Council (GCC) — formally the Cooperation Council for the Arab States of the Gulf — is a political and economic union comprising six member states:
- Saudi Arabia
- United Arab Emirates (UAE)
- Bahrain
- Kuwait
- Oman
- Qatar
The GCC has developed harmonised standards and frameworks across multiple sectors, including healthcare and medical devices.
GCC medical device harmonisation
GCC member states have worked toward harmonising medical device regulatory requirements, with the goal of streamlining market access across all six countries. However, each member state maintains its own national regulatory authority and registration process:
| Country | Regulator |
|---|---|
| Saudi Arabia | SFDA |
| UAE | Ministry of Health and Prevention / MOHAP; Dubai Health Authority (DHA); Abu Dhabi Department of Health (DoH) |
| Kuwait | Kuwait Drug and Food Control Authority |
| Bahrain | National Health Regulatory Authority (NHRA) |
| Oman | Ministry of Health |
| Qatar | Ministry of Public Health (MOPH) |
GCC group purchasing programme
The GCC has a group purchasing programme that covers all member states, offering manufacturers who are registered across multiple GCC markets the opportunity to participate in joint procurement tenders. Registration in Saudi Arabia (as the largest GCC market) is often the first step toward a broader GCC market strategy.
Practical implications for manufacturers
- An SFDA MDMA does not automatically grant market access in other GCC countries — each country requires its own registration
- The alignment of classification rules (EU MDR-based) across GCC countries simplifies technical file preparation for multi-country submissions
- Manufacturers entering the GCC should consider a coordinated registration strategy across all target markets