Medical Devices

Medical Devices Compliance for Australian Companies Expanding to United Arab Emirates

Medical device manufacturers in Australia 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 Australia 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.

Technical File Creation

We compile and review your Technical File to ensure it meets all regulatory requirements, including design specifications, testing data, and risk management documentation.

Risk Management

We support risk assessments and management processes to help identify, document, and mitigate potential product risks in line with ISO 14971.

QMS Supplier Audit

Supplier compliance is critical for medical devices. We assess your suppliers’ QMS performance to ensure regulatory and quality requirements are met.

What we do

Device Registration

Complete registration process with Ministry of Health and Prevention (MoHAP), Dubai Health Authority (DHA), or local emirate authority for UAE market authorization.

Local Agent Services

We act as your authorized local agent in UAE, handling authority communications, registration maintenance, and liaison with MoHAP or DHA for regulatory compliance.

Import & Customs

Import permit applications, customs clearance support, Certificate of Free Sale requirements, and regulatory approvals for medical device importation into United Arab Emirates.

Classification

Unsure how your product is classified? We determine the correct classification, ensuring you follow the right regulatory pathway.

Classification & Standards

Device classification under UAE requirements, conformity with GMDN nomenclature, and compliance with relevant ISO standards for United Arab Emirates market entry.

Technical File Review

Technical documentation review and preparation meeting UAE requirements, including certificates of conformity, quality system documentation, and clinical evidence.

GCC Recognition Support

Gulf Cooperation Council mutual recognition support, multi-emirate registration coordination, and ongoing compliance maintenance for UAE and broader GCC market access.

QMS Audit Support

Facing a Notified Body audit or regulatory inspection? We provide hands-on support to help you prepare, respond, and maintain compliance throughout the process.

Testimonials

Our happy clients say about us

Bethany has a wealth of experience in medical devices and is always providing a fantastic service. Having worked with Bethany on and off over the years I can safely say I would trust her regulatory advice. Thank you Taylored & the team!

The Cosmetic Regulator

We have been working with Bethany for 3 months now and are very impressed! She is super orgainsed, very knowledgable and does it all with a smile! Would highly recommend.

George Kruis

Amazing! Went over and above working longer hours communicating with suppliers and getting all the relevant info. Quick to find solutions and overall very helpful. Thank you!

Tom Attwood

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