Medical device registration process in UAE

-By KI News Team | Oct. 21, 2020, 8:46 a.m.

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

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

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

Product Registration Requirement:

  • Application form of product and company
  • CE certificate and FSC
  • Declaration of Conformity
  • Company registration certificate in 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