Medical Devices Registration: Vital Steps in UAE

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Medical Device and its Classification as per UAE Ministry of Health and Prevention (MoHAP)

In UAE, the process for medical device registration is overseen by the United Arab Emirates Ministry of Health & Prevention (MoHAP), tasked with upholding safety and efficacy standards. United Arab Emirates Ministry of Health & Prevention (MoHAP) is crucial in evaluating and approving medical devices before they are imported and traded in the UAE.

As per the UAE Ministry of Health & Prevention, “any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material, or another similar or related article” is defined as a Medical Device. The classification of Medical Devices are divided into the following four categories:

Class I	Risk – low level
Class IIa	Risk – low to moderate level
Class IIb	Risk – high to moderate level
Class III	Risk – high level

Process for Registration of Medical Device as per UAE Ministry of Health and Prevention (MoHAP) Guidelines:

With the help of the UAE pass, login to the MoHAP website/smart app.
Using the electronic service, submit the request. Meet all conditions to complete the payment.
The competent technical committee will deliberate the registration of products & recommendations shall be submitted to the competent ministerial committee.
The concerned companies shall be addressed through letters stating the committee’s decisions.
The customer shall follow up with the Analysis Section of the Drug Department.
After follow-up, the company shall complete the requirements & submit them through electronic service.
The re-deliberation of the registration of products that are deferred in advance shall be done by relevant technical and ministerial committees as soon as companies complete the requirements.
The certificate of registration of approved products will be issued provided all the conditions and requirements are fulfilled. Kindly note: The validity of registration of the certificate is for five years effective from the date of the committee’s approval.
For locally manufactured pharmaceutical products, pharmaceutical certificates shall be issued which are only valid for one year effective from the date of issuance.

Required Documents for Medical Device Registration

The application form of registration has to be filled, signed, and stamped by the company.
A copy of the valid registration certificate of the medical device manufacturing factory shall be submitted.
A valid certificate of free sale/ registration certified by the Embassy of UAE issued by competent authorities in the country of origin.
A copy of the product agency contract signed between the medical device company and the agent is to be submitted.
Quality conformity/ market authorization certificates such as 510k (premarket notification), EC (European Conformity), and PMA (Parts Manufacturer Approval) as per equipment classification, i.e. Class I, II, III, IV.
Post-marketing monitoring guidelines or requirements.
The details regarding the medical device such as description, formulation, types, sizes, models, accessories, usages, side effects, contradictions, warnings, precautions, usage guidelines, photos of packaging covers, brochures, and usage manuals.
Laboratory requirements, analysis, and pricing for certain medical equipment are required.
One sample, certificate of analysis (as per equipment type), external and internal covers, and brochures of the medical device are required.
The company has to proclaim that the equipment conforms to Medical Equipment Manual (EC(European Conformity)-Declaration of Conformity) specifications.
Data for safety and efficacy (only for products classified as Class III, IV).
There is a special requirement as well for a Certificate of Conformity for equipment that is manufactured from animal products.

Conditions & Requirements

Before registering their products, the Marketing Authorization Holder companies must get themselves registered by MoHAP.
The Ministry of Health & Prevention must license the marketing office or medical warehouse and must have a valid license.

Timeline & Fees

Description	Fee (AED)	Time Duration
Application of Medical Devices	100	45 working days
Registration of Medical Devices	5,000	45 working days

Maven Profcon Services LLP offers comprehensive regulatory consultancy services for medical device manufacturers. Whether you need support with Quality Management Systems (QMS), ISO13485 certification, Country Registrations, USFDA 510k submissions, MDSAP, or EU MDR compliance, we’ve got you covered. Our team is dedicated to providing everything you need under one roof, ensuring a seamless and efficient path to regulatory compliance.

To connect with us and get your Medical device registered in UAE, please reach out to us through enquiry@mavenprofserv.com or call us at +91-7490017774 / +91 7940026222