Regulatory Affairs for Pharma & Medical Devices in the GCC

Every medicine and medical device sold in the Gulf reaches patients because someone planned its registration, built its dossier and kept it compliant after approval. The rules are changing fast: the UAE moved product regulation from the Ministry of Health and Prevention to the Emirates Drug Establishment, and in 2026 Saudi Arabia updated its reliance pathways for medicines and introduced one for devices. This SkillCert Specialist course shows you how regulatory affairs work is done across the UAE, Saudi Arabia, Qatar, Kuwait, Oman and Bahrain. You will identify the right regulator, classify borderline products, and choose between national registration, the GCC central route and reliance pathways. You will also build a GCC-ready CTD dossier with compliant Module 1 and Arabic labelling, and handle GMP evidence, stability, pricing and launch. For devices and IVDs, you will plan registrations country by country, including the Saudi MDMA. Finally, you will keep products compliant through variations, pharmacovigilance, device vigilance and renewals. The course reflects the rules as of October 2026. Each module includes a practical template you can use at work, and workplace scenarios let you practise the decisions you will make on the job.

Regulatory affairs staff are needed by every manufacturer, distributor, local agent and marketing office that sells medicines or medical devices in the Gulf. With the UAE's new Emirates Drug Establishment, Saudi Arabia's expanding reliance pathways and mandatory device registration in Bahrain and Oman, employers need people who can file correctly the first time and keep products compliant. This course pairs well with the Pharmaceutical Microbiology & Contamination Control and ISO/IEC 17025 SkillCerts.