Bahrain is a dynamic and business-friendly market in the GCC, with strong healthcare investments and demand for high-quality pharmaceuticals, medical devices, and health products.
The National Health Regulatory Authority (NHRA – الهيئة الوطنية لتنظيم المهن الصحية) is the primary regulatory body in Bahrain responsible for the registration, importation, distribution, quality control, and post-market oversight of medicines, medical devices, cosmetics, and related health products. NHRA aligns with GCC harmonized standards (including GHTF/IMDRF) and requires product registration, import permits, GMP compliance, quality certificates, and local representation for foreign manufacturers. MedWisdom LifeScience provides expert regulatory affairs support to help global companies navigate Bahrain’s requirements, prepare compliant dossiers, secure NHRA approvals and import authorizations, and achieve efficient market entry and sustained compliance in this strategic GCC market.
Get Bahrain Compliance Support
Preparation of regulatory dossiers (CTD format), supporting documents (stability, preclinical/clinical data, GMP/CPP certificates), and quality review for NHRA submissions.
End-to-end support for NHRA registration of medicines, medical devices, cosmetics, and health products in Bahrain.
Assistance with NHRA import/export authorizations, batch release certificates, customs documentation, and special import permits.
Guidance on GMP documentation, quality assurance requirements, certificate support, and preparation for NHRA quality inspections.
Setup of pharmacovigilance systems, adverse event reporting to NHRA, periodic safety reporting, and risk management in Bahrain.
Support for post-market monitoring, vigilance reporting, field safety corrective actions, and compliance with NHRA post-registration requirements.
Arabic/English labelling review, NHRA-specific requirements (patient information, packaging), mock-up preparation, and compliance support.
Support for local agent/representative requirements, NHRA liaison, regulatory follow-up, and ongoing compliance management in Bahrain.
Strategic market entry planning, NHRA pathway guidance, regulatory intelligence on Bahrain’s requirements, and risk mitigation support.
Partner with Medwisdom for expert, reliable, and compliant regulatory support in Bahrain — from NHRA product registration and import permits to pharmacovigilance, Arabic labelling, and sustained GCC market access.
Contact Our Bahrain Regulatory Experts