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Medical Device Registration and Market Entry Strategy in the UAE

BY KENTRON RESEARCH

The United Arab Emirates is the second-largest economy in the Middle East. A most diversified prominent country in GCC. The country is an import driven market in terms of the medical device industry. Medical and drug approval is regulated by the Drug Control Department of the Ministry of Health (DCD MOH). The govt of UAE is pushing the campaign to increase medical tourist from neighbour countries.

The medical device industry in the UAE is growing at a compound annual rate of 8 per cent and may reach $1.4 billion in 2021.

The medical device in the UAE is divided into four categories (Class I, IIa, IIb, and III). The classification and regulation are as per international standards. The device already approved in other countries goes through a simplified registration process in the UAE.

ClassificationDescriptionRisk Level
Class IThe subject requires the lowest level of regulation due to low risk to the patient except for sterile productsLow
Class IIInvasive with the human body, but the methods of invasion are limited to natural body hole. It includes therapeutic devices used in diagnosis or in wound managementLow – Moderate
Class IIIPartially or totally implantable within the human bodyHigh – Moderate
Class IVRequires design/clinical trial reviews, product approval and post-market result involving clinical trials. High

Product Registration Requirement:

  • Application form of product and company
  • CE certificate and FSC
  • Declaration of Conformity
  • Company registration certificate in the UAE
  • Devices distribution status
  • Declaration of prices
  • Post-market assessment
  • Manufacturing process
  • Labelling and Sampling
  • Shelf Life Study

Major players (In the private healthcare market)

  • NMC Healthcare
  • Al-Noor Medical Company
  • VPS Healthcare
  • Tumbay group
  • Al-Zahra Group
  • Belhoul Lifecare
  • Emirates Healthcare
  • Gulf Healthcare International
  • Gulf Medical Projects Company
  • Zulekha Hospital
  • Saudi German Hospital Group
  • GE Healthcare
  • Aster DM Healthcare
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