Medical Devices
Medical device manufacturers in Europe seeking to enter the United Arab Emirates market must comply with local medical device regulations and demonstrate conformity through comprehensive technical documentation. Ministry of Health and Prevention (MoHAP) oversees medical device regulation in United Arab Emirates, requiring manufacturers to establish proper representation and meet stringent safety and performance requirements.
Taylored Consultancy provides complete medical device regulatory support for Europe companies expanding to United Arab Emirates. Our services include device classification, technical file preparation, clinical evaluation, UK Responsible Person (UKRP) or EC Representative (EC-REP) services, and ongoing post-market surveillance to ensure full compliance throughout your product lifecycle.
Complete registration process with Ministry of Health and Prevention (MoHAP), Dubai Health Authority (DHA), or local emirate authority for UAE market authorization.
Device classification under UAE requirements, conformity with GMDN nomenclature, and compliance with relevant ISO standards for United Arab Emirates market entry.
We act as your authorized local agent in UAE, handling authority communications, registration maintenance, and liaison with MoHAP or DHA for regulatory compliance.
Technical documentation review and preparation meeting UAE requirements, including certificates of conformity, quality system documentation, and clinical evidence.
Import permit applications, customs clearance support, Certificate of Free Sale requirements, and regulatory approvals for medical device importation into United Arab Emirates.
Gulf Cooperation Council mutual recognition support, multi-emirate registration coordination, and ongoing compliance maintenance for UAE and broader GCC market access.
