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Medical Device Registration Guideline Registration and Drug Control Department Ministry of Health UAE 2011 1 Acknowledgement This guideline was prepared by a technical team under the supervision.

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Filling out the application form of registration completely and to be signed and stamped by company. A copy of valid registration certificate of the factory. A valid certificate of free sale/ registration issued by the competent authorities in the country of origin certified by the Embassy of the United Arab Emirates.

Required Documents Valid MOHAP medical store license. Valid MOHAP license of Pharmacist in-charge, or Medical Equipment Engineer Certificate attested by the UAE Ministry of Education- for medical store that has activity of only non-pharmaceutical medical devices.

FDA regulates the sale of medical device products (including diagnostic tests) in the U.S. and monitors the safety of all regulated medical products. In the U.S., FDA regulates the sale of medical device products.

The medical device regulation (MDR) or European Union medical device regulation (EU MDR) is a new set of regulations that govern the clinical investigation, production and distribution of medical devices in Europe.

The MOHAP is the authority in charge of all medical products and devices within the UAE. They cover all matters set out in the Pharmaceutical Law. All medical devices must be registered and licensed whether including those registered in other jurisdictions.

Registration of a Medical Equipment | Services | Ministry of Health and Prevention - UAE.

The United Arab Emirates' Ministry of Health and Prevention (MOHAP) is the government authority in charge of medical device registration, as well as regulations for other medical products, including prescription and over-the-counter pharmaceutical products.

Medical devices in the UAE are categorized into four risk-based types (Class I, II a, II b, and III) under the jurisdiction of the Drug Control Department of the Ministry of Health (DCD MOH).

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© Copyright 1997-2025
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Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
All Forms
Search all Forms
Industries
Forms in Spanish
Localized Forms
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232