Product Registeration in United Arab Emirates | Medical Device and IVD Registeration in U.A.E| MoHAP

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Product Registeration in United Arab Emirates | Medical Device and IVD Registeration in U.A.E| MoHAP@ivdmanufacturing7208

An Overview of Medical Device Regulations and Requirements in the United Arab Emirates
What is MOHAP
Ministry of Health and Prevention (MOHAP)
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.
-evaluating and approving medical devices before they are imported and traded in the UAE.
-designs and builds hospitals and other healthcare facilities
-launches health promotion initiatives to inform the public about healthy habits and illness prevention.

Medical Device Definiton
“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.

UAE Medical Device Classification
UAE has separate Classification Rules for Medical Devices and IVDs. The UAE medical device classification rules are in line with the classification rules of the EU Medical Device Directives. The class of devices as per the UAE classification rules are as below

Risk Criteria Medical Device Class
Low Risk I
Low Moderate Risk IIa
Moderate – High Risk IIb
High Risk III

Medical Device Registeration

Regulatory Pathway

UAE Local Authorized Representative


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