Regulatory Approvals

Product Registrations and Regulatory Services

Getting medical products approved in the UAE involves a rigorous process to ensure safety, efficacy, and quality before it can be introduced into the market.
The approval pathway can vary by product, but generally follows similar principles, guidelines, technical documentation
and validations conducted in developed countries.

Product Categorization

The foundational block of product registration is the categorization into a medical and/or a non-medical device. As a licensed medical equipment trading company, we facilitate the initial categorization of products.

MOHAP Product Licensing

The core of the application process is to access the quality of the product and the safety of the consumer when used. This process is the most crucial stage of your medical product to be rolled out in the market and needs to be approved by MOHAP.

Manufacturer Licensing

Every medical equipment manufacturer needs to be registered with MOHAP. Our team of regulatory experts will help you define the right application, facilitate the required documentation before submitting the requirements for review and approval.

Safety & Security Evaluations

All the Product approvals under-go scrutiny for Safety & Security Standards, while the primary responsibility of the technical documentation is with the supplier. At Alpha Health we facilitate and hand-hold the process for accuracy of submissions.

MOHAP Medical Warehouse

One of the important process to be navigated with the MOHAP is the registration of a MOHAP approved medical warehouse. There are several ways in which this can be achieved, reach-out to our team for advice.

Quality Management Systems

Every product under approval needs to evidence appropriate Quality Management. Processes are being followed and thorough evaluations are being conducted before they are being sold in the relevant markets.

MOHAP Medical Store

The regulations mandate the importation and selling of medical devices only via a MOHAP approved medical warehouse. At Alpha Health we can facilitate this partnership through our network channels and help comply the requirements.

Post Approvals Monitoring & Controls

On approval, all products needs to be kept active and license renewed timely. The active products need responsible and accountable grievance management procedures with reporting and responding to customer complaints.

Contact Us

Get high-quality service with quality Products

1500+ Channel
Partner Association

Frequently asked questions

01. What are regulatory services in the context of medical equipment?

Regulatory services involve ensuring that all medical equipment complies with relevant industry standards, government regulations, and safety requirements. This includes obtaining necessary certifications, conducting product testing, and maintaining documentation to ensure that devices can be legally sold and used in the market.

02. How does your company assist with FDA or CE marking approvals?

We guide clients through the FDA (Food and Drug Administration) or CE (Conformité Européenne) marking approval process by preparing and submitting required documentation, conducting risk assessments, and ensuring that all equipment meets the stringent standards necessary for market entry in the U.S. or European Union.

03. Can your company help with international regulatory compliance?

Yes, we provide support for navigating international regulatory requirements, ensuring that your medical equipment meets the standards of different countries and regions. This includes assistance with certifications, translations of necessary documents, and alignment with local regulations.

04.What kind of documentation support do you offer for regulatory compliance?

We offer comprehensive documentation services, including the preparation of technical files, risk management reports, clinical evaluations, and other essential records that demonstrate compliance with regulatory standards.

05.How do you keep up with changes in regulatory requirements?

Our team stays updated on regulatory changes through continuous monitoring of industry standards, government guidelines, and legal updates. We provide proactive advice and updates to ensure that our clients remain compliant with the latest regulations.

+971 4 457 0418

marhaba@alphahealth.me

Medical and Healthcare products distribution company committed to provide high-quality Medical & Healthcare products and services, using innovative solutions, bridging the gap between manufacturers, consumers and healthcare providers.