Crucial Steps: Understanding the Complete Process of Medical Product Registration

A wisely thought through business is an initial tool that is utterly crucial to any start-up’s success. While it is a way to have a very clear understanding of the path, the company will have to follow to ultimately reach commercialization, including how much the process will cost and what the several goals and value inflection points are along the way to register medical devices in Dubai.

If we talk about the medical product market, It has been examined based on,

• In-Vitro Diagnostics (IVD),
• Cardiology,
• Orthopedics,
• Diagnostic imaging,
• Ophthalmic,
• General and plastic surgery,
• Drug delivery,
• Endoscopy,
• Dental,
• Wound management,
• Diabetic care,
• Nephrology,
• Ear, Nose, and Throat,
• General hospital and Healthcare,
• Neurology,
• Skin Care,
• Aesthetics and other products.

The medical device market size was valued at USD 19.6 billion in 2016 and is expected to grow at a CAGR of over 5.5% over the forecast period.

The United Arab Emirates medical device market will record an evolution. With rising medicinal services costs, the administration will build private division support.

Those who are willing to set up the manufacturing business of the medical products, need to understand the complete process of Medical products registration process.

The registration process of Medical products in Dubai

Most establishments that are required to register are essential to list the devices and the activities performed on the tools at that establishment.

Owners of a business that are involved in the production and distribution of medical devices intended for use in the United States (U.S.) are required to register. This progression process is known as establishment registration.

Most foundations that are required to enroll with the FDA are likewise required to list the products that are made there and the exercises that are performed on those products. If a device requires premarket approval or notification before being marketed in the UAE, then the owner should be responsible for the FDA premarket submission.

The registration of a medical device is a two-step process. First, you must pay the annual registration fee. After spending the payment, you can then complete the registration process. The registration is not completed until you have,

• Pay your annual registration fee,
• Submit your registration and listing information and Received email notification from FDA that all requirements have been met.

Step by Step guidance for better understanding the process to register medical devices in Dubai

1. You will receive your Payment Identification Number (PIN) when you make your payment on the DFUF site. 

2. You will get a warning of installment affirmation and guidelines on getting your Payment Confirmation Number (PCN) by email once your installment has cleared. This process can take several days, so be sure to make payment at least a few days before registering.

3. If you have never previously registered a device establishment, you will need to first create an FDA Industry Page (FURLS) account for the owner/operator

3. If you have never previously registered a device establishment, you will need to first create an FDA Industry Page (FURLS) account for the owner/operator

4. Once you have set up your FURLS account ID and password, select the DRLM button.

5. Select the link “Register a Medical Device Facility” from the DRLM main menu.

6. Certify that all the information is correct and click on the submit button.

The medical devices must be registered with the MOH. In the complete process to register medical devices in Dubai, you will need an experienced and knowledgeable person to stand by the side and assist you. Our efficient team has been serving people with their experience from several years in this field, and our team is dedicated to customer satisfaction and quality service. Click Here to Contact MSZ or Email to info@msz.ae.