Introduction

Many manufacturers believe UAE market access is simply about submitting documents. Successful entry requires regulatory planning, legal structuring, and long-term compliance management.

1- Regulatory Foundation

All medical devices must be registered with MOHAP before importation and commercialization. The registration certificate is valid for five years.

2- Choosing the Right Market Model

Manufacturers must decide:

• 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.

3- 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.

4- Strategic Advice

Early gap assessment, document legalization planning, and Arabic labeling review significantly reduce review time.