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Medical Device Registration Consultant

Medical Device Registration Into Dubai

  • The healthcare sector of the United Arab Emirates (UAE) is highly dependent on the import of medical devices. Given the incredible infrastructure of the region and its strategic location, it is an appealing hub for the distribution of medical devices.
  • UAE Medical Device Regulations

  • The UAE has a number of healthcare regulators at both the Federal and Emirate levels. However, the control and regulation of medical devices is supervised and directed by the UAE Ministry of Health (MoH) Registration and Drug Control Department.
  • The medical device registration guidelines released by the UAE MoH in 2011 makes reference to the Global Harmonization Task Force (GHTF), the World Health Organization (WHO), the US Food and Drug Administration (FDA), Health Canada, the European Council Directives, the Therapeutic Goods Administration (TGA) of Australia and the Health Science Authority (HSA) of Singapore.
  • The manufacture has to appoint the local representative to act on its behalf to register devices and comply with local regulations. The local representative shall have a valid establishment license issued by the MoH.
  • The Registration Process

  • The manufacturer/local representative must submit a medical device registration application form to the MoH Drug Control Department.
  • The technical requirements that are to be submitted with the application file are based on the classification of the medical device. Table 2 in Annex 8 of the UAE medical device guidelines summarises the main classes for General Medical Devices and In-Vitro Diagnostics and the required documentation for each. The application can be written in English or Arabic.

  • Medical device approvals or clearance from a recognized regulatory authority (i.e., US FDA, Health Canada, Japan MHLW, TGA Australia or EU) can be used to abridge the evaluation process for medical devices to be marketed in the UAE.
  • Upon approval by the UAE MoH, the applicant will receive a registration certificate that is valid for five years.