UAE – Medical Device Registration for Israeli Companies
The Regulatory Process in the UAE
- Fill and submit the classifcation application form.
- 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.
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.
- Prepare Technical Regulatory documents.
- Appoint an Authorized Representative and License Holder (AR/LH).
- Register manufacturer and products – Document preparation and submission to the UAE authorities.
- Obtain sales clearance in the UAE.
- 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.