UAE – Medical Device Registration for Israeli Companies

The recent peace agreement brings immediate commercial opportunities for Israeli medical technology in the United Arab Emirates and through it to other members of the Gulf Cooperation Council (GCC). Arazy Group Consultants Inc. has been operating in these markets for the past eight years registering medical and IVD devices in the UAE, Bahrain, Kuwait, Oman, Qatar, and Saudi Arabia for manufacturers worldwide. We are now pleased to offer our experience and know-how to the innovative Israeli medical and IVD industry. Also, Arazy Group’s office in the UAE provides Authorized Representative and License Holder services, giving the manufacturer independent market access and not having to rely on a chosen distributor.

The Regulatory Process in the UAE

There are two ways to export medical devices to the UAE:
                                                                                                                                                                                                                                              1. The Interim Process: Import Permit is a process that allows the importation of medical devices intended for professional use to the UAE in parallel to the registration process. This service is performed through the local Authorized Representative and charged per shipment.
                                                                                                                                                                                                                                              2. The Official Process: In the United Arab Emirates, a two-step process is required. The first step is a mandatory meeting with the competent authority to determine the classification of the products. This process takes 2 – 3 months. The authorities may request samples of the product. Based on the decision made in the meeting, a second step of the product registration takes between 8 – 9 months (in addition to the official survey). The full process until registration takes 10 – 12 months, assuming the manufacturer provides all the required compliance documents required for Step One.
Step One
  1. Fill and submit the classifcation application form.
  2. Schedule an appointment with the responsible regulatory officer at MoH to review the form and, once accepted, wait for the committee meeting and a product classification decision.
The 3 possible outcomes are:

a. The product is not considered a medical device: In this case, the Competent Authority will issue a letter to confirm it.

b. The product is considered a medical device and requires registration: The project continues to Step Two.

c. The product is considered a medical device but doesn´t require registration: In this case, the Competent Authority will issue a letter stating as such. The letter must be renewed every year and by the appointed authorized representative. The Competent Authority is entitled to request the registration of the device at any point in the future.

Step Two
  1.  Prepare Technical Regulatory documents.
  2. Appoint an Authorized Representative and License Holder (AR/LH).
  3. Register manufacturer and products – Document preparation and submission to the UAE authorities.
  4. Obtain sales clearance in the UAE.
Important Comments

 

  • The license holder is the only company authorized to import the products into the UAE. Arazy Group’s office in the UAE is acting as an independent third-party Authorized Representative and holds licenses on behalf of the manufacturer, providing the importation management services.
  • Government official fees are AED 500 per product form (approx. $137 USD).
  • TO REGISTER A PRODUCT IN THE UAE, THE PRODUCT MUST HAVE AN ACTIVE REGISTRATION IN ONE OF THE FOLLOWING COUNTRIES: USA, EU, JAPAN, CANADA or AUSTRALIA.

Arazy Group’s global online Medtech registration platform LICENSALE® manages medical and IVD devices in 140 countries, faster and more cost-efficiently than any other practice. Learn more about our products and services today.

Get in Touch with us for More Information!

Our team will reach out to discuss your company’s personal registration projects in the UAE or any other inquiries you may have.


* Note: If you use your general ISP e-mail address, such as gmail, yahoo etc. your LinkedIn profile address is required to process your request.