Oman is a stable and growing market in the Gulf Cooperation Council (GCC), with increasing healthcare investments and strong demand for high-quality pharmaceuticals, medical devices, and health products.
The Directorate General of Pharmaceutical Affairs & Drug Control (DGPA&DC) under the Ministry of Health (MoH – وزارة الصحة) is the national regulatory authority responsible for the registration, importation, distribution, quality control, and post-market oversight of medicines, medical devices, cosmetics, and related health products in Oman. Oman aligns closely with GCC harmonized standards and requires product registration, import permits, GMP compliance, and local representation for foreign manufacturers. MedWisdom LifeScience provides expert regulatory affairs support to help global companies navigate Oman’s requirements, prepare compliant dossiers, secure MoH approvals and import authorizations, and achieve efficient market entry and sustained compliance in this promising GCC market.
Get Oman Compliance Support
Preparation of regulatory dossiers (CTD format), supporting documents (stability, preclinical/clinical data, GMP/CPP certificates), and quality review for MoH submissions.
End-to-end support for MoH registration of medicines, medical devices, cosmetics, and health products in Oman.
Assistance with MoH import/export authorizations, batch release certificates, customs documentation, and special import permits.
Guidance on GMP documentation, quality assurance requirements, certificate support, and preparation for MoH quality inspections.
Setup of pharmacovigilance systems, adverse event reporting to MoH, periodic safety reporting, and risk management in Oman.
Support for post-market monitoring, vigilance reporting, field safety corrective actions, and compliance with MoH post-registration requirements.
Arabic/English labelling review, MoH-specific requirements (patient information, packaging), mock-up preparation, and compliance support.
Support for local agent/representative requirements, MoH liaison, regulatory follow-up, and ongoing compliance management in Oman.
Strategic market entry planning, MoH pathway guidance, regulatory intelligence on Oman’s requirements, and risk mitigation support.
Partner with Medwisdom for expert, reliable, and compliant regulatory support in Oman — from MoH product registration and import permits to pharmacovigilance, Arabic labelling, and sustained GCC market access.
Contact Our Oman Regulatory Experts