A. Melnikov, V. Shalaeva. Key Rules and Procedures for Registering Medical Devices in the UAE

A step-by-step look at classifying a device, choosing a route to market, registering the applicant company or working through a distributor, and registering the device itself with MOHAP.

Introduction

MOHAP's regulatory policy references the directives of the following national regulatory bodies:

• the US Food and Drug Administration (FDA),
• EU Council Directives 90/385/EEC and 93/42/EEC,
• Health Canada,
• the Asian Harmonization Working Party (AHWP),
• Singapore's Health Sciences Authority (HSA).

UAE regulations divide medical devices into four risk classes:

• Class I — low risk
• Class II and III — medium risk
• Class IV — high risk

Class IV, high risk

• Devices that affect the functioning of vital organs and/or life-support systems, including invasive devices intended to sustain life, or devices used to prevent deterioration in a person's health, or devices that present a potential unwarranted risk of illness or injury.
• Additional technical and clinical testing may be required.

Stage 1. Classifying the medical device

Requirements:

• a description of the medical device,
• images/screenshots of the medical device,
• certificates and test reports (notarized, in English),
• an Emirates ID and a UAE Pass are required to file the application.

The regulator may raise additional questions during review, which is why the real timeline runs longer than the official one.

Market rate for expert services — from $1,500, covering:

• preparing the application,
• filing the application,
• supporting the application through review,
• answering the regulator's questions,
• requesting clarification of the findings.

Some types of devices do not require registration or prior import authorization, and are instead regulated at the point of import itself.

In our experience, devices that already hold a medical CE mark or FDA clearance can sometimes be classified as not requiring registration in the UAE (a case involving software for accelerating MRI image processing).

There are also situations where a device that is non-medical in Europe still requires registration in the UAE (a case involving cosmetology equipment).

Once classification is complete, the company faces its first fork in the road:

• Option 1: register the medical device under your own company, with mandatory registration of that company with MOHAP.
• Option 2: register the medical device under a distributor that is already registered with MOHAP.

Stage 2.1. Registering the company with MOHAP

Requirements:

• a legal entity registered in the UAE,
• a warehouse or pharmacy that meets MOHAP requirements (holding a MOHAP license, and meeting ISO 13485 requirements),
• a pharmacist on staff holding a license to practice pharmacy in the UAE.

Market rate for expert services — $5,000, covering preparation and support throughout the process.

Stage 2.2. Working with a registered distributor

Requirements:

• an agreement with the distributor,
• the distributor must hold a MOHAP license, and therefore a licensed warehouse or pharmacy, and a pharmacist on staff holding a license to practice pharmacy in the UAE.

Once the party registering the device has been decided, a second fork in the road follows:

• Option 1. Registration based on an existing FDA clearance or CE mark.
• Option 2. Registration of the medical device without an FDA clearance or CE mark.

The document package required for filing with MOHAP is the same under both options. But under the second option:

• the process takes around 2 years,
• given the need to develop a complete set of documentation,
• and to run every applicable test in laboratories holding ISO/IEC 17025 international accreditation, using methods that satisfy the relevant private standards applicable to the device, in any country.

Stage 3. Registering the medical device

Requirements:

• a description of the device,
• a CE or FDA certificate (where held),
• a technical file meeting MDR/FDA standards, plus other required technical documentation,
• test reports from accredited laboratories for every applicable test — first and foremost, evidence confirming the device's safety and efficacy,
• an ISO 13485 certificate for the manufacturing site.

Market rate for expert services — $10,000, covering preparation of the application and support throughout the process.

The UAE register of medical devices

Registration validity period:

• 5 years, or until suspended or revoked by the authorities.
• Continued validity depends on submission of post-market surveillance reports.
• Every 2 years for certain high-risk devices (Class III, IV) identified by the Drug Registration and Control Department as requiring special attention.

Language of labelling and documentation

Labelling and documentation must be provided in English.

Required documents

• the registration form, filled in completely, signed and stamped by the company,
• a copy of the manufacturer's current registration certificate,
• a current certificate of free sale/registration issued by the competent authorities of the country of origin, legalized by a UAE embassy,
• a copy of the agency agreement signed between the company and its authorized representative,
• a quality conformity certificate/registration certificate — for example CE (European conformity), 510(k) (US premarket notification), or PMA (premarket approval), matching the device's classification, i.e. Class I, II, III or IV,
• post-market surveillance requirements,
• product information, including: description, composition, types, sizes, models, accessories, methods of use, side effects, contraindications, warnings, precautions, usage recommendations, photographs of packaging, brochures and instructions for use,
• laboratory requirements and test results, together with pricing for the equipment in question,
• submission of one sample, a certificate of analysis (depending on the type of equipment), and outer and inner packaging and brochures,
• the company's confirmation that the equipment meets the specifications of the relevant medical device guidance (European conformity — Declaration of Conformity),
• safety and efficacy data (for products classified as Class III or IV),
• special requirement: a conformity certificate for equipment manufactured using materials of animal origin.

Authors

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