Question 1

Do medical devices and pharmaceuticals both need registration in the UAE?

Accepted Answer

Yes. Products like medical devices, pharmaceuticals and in-vitro diagnostics all require registration with MOHAP or other authorised bodies.

Question 2

Who can act as the local authorised representative?

Accepted Answer

A UAE-licensed distributor or local entity must be appointed; Montgo can serve or help you appoint the correct local partner.

Question 3

How long does registration usually take?

Accepted Answer

While timelines vary by product complexity and class, many approvals can be achieved in 45 working days when all documents are in place.

Question 4

What documents are typically required?

Accepted Answer

Technical file, risk assessments, GMP/ISO certificates, free-sale certificates from origin country, labeling in English/Arabic and local agent info.

Question 5

Is registration valid indefinitely?

Accepted Answer

No. Once approved, registration certificates are valid for a period (often five years); you’ll need to manage renewals and post-market duties.

Question 6

Can Montgo assist with global product registration as well?

Accepted Answer

Yes. Our regulatory team has insight in UAE, GCC and global markets—supporting both local registration and export readiness.

Question 7

What happens if my product fails to meet UAE requirements?

Accepted Answer

Montgo conducts remedial gap analysis, advises on necessary modifications, and supports re-submission to meet regulatory standards.

Question 8

Why register your product rather than import without registration?

Accepted Answer

Without registration, importation or sale is illegal in UAE healthcare market. Proper registration ensures compliance, market access and buyer trust.

Medical Devices & Pharmaceutical Product Registration