Many manufacturers believe UAE market access is simply about submitting documents. Successful entry requires regulatory planning, legal structuring, and long-term compliance management.
Regulatory Foundation
All medical devices must be registered with MOHAP before importation and commercialization. The registration certificate is valid for five years.
Choosing the Right Market Model
Appoint a local distributor as MAH Establish their own UAE entity Work through a regulatory partner Each model impacts pricing control, exclusivity, and long-term strategy.
Risk-Based Classification
Device classification (Class I–IV) determines: Depth of technical documentation Whether safety & efficacy studies are required Level of committee scrutiny Incorrect classification is a common cause of delay.
Strategic Advice
Early gap assessment, document legalization planning, and Arabic labeling review significantly reduce review time.
