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Medical Devices Registration in UAE

  • Medical Devices Market in India is at $11 billion, poised to grow to $50 billion over the next five years

  • India’s current share in the global market is at 1.5%, poised to grow to 12% over the next 25 years

  • India imports 75% of its medical devices currently 

  • Key products marketed in India include Medical and Surgical Instruments; Medical Imaging Equipment; Electro-Medical Equipment; Orthopedic and Prosthetic Appliances; Cancer Diagnostic Solutions; Ophthalmic Instruments and Appliances; Orthodontic Equipment and Dental Implants; Point of Care Testing (POCT) Diagnostic Devices; Digital Healthcare, Health IT, and Telemedicine Services. 

Regulatory Authorities in India for Medical Devices

Ministry of Health and Prevention (MOHAP) regulates medical devices in UAE.

Any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material, or another similar or related article: a) intended by the company and its manufacturing site to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of:

  • Diagnosis, prevention, monitoring, treatment, or alleviation of disease.

  • Diagnosis, monitoring, treatment, alleviation of, or compensation for an injury.

  • Investigation, replacement, modification, or support of the anatomy or of a physiological process.

  • Supporting or sustaining life.

  • Control of conception.

  • Disinfection of medical devices.

  • Indicate the sterilization process completion.

  • Providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body.

b) which does not achieve its primary intended action in or on the human body by pharmacological, immunological, or metabolic means, but which may be assisted in its intended function by such means.

Medical Devices Registration Services in UAE

  • Authorized Representative and Import Services

  • Gap Analysis

  • Regulatory Intelligence and Strategy

  • Consultation and Meeting

  • Technical File Preparation and Submission

  • Quality Management System Implementation

  • Audit Support

  • Quality Training

  • Response to Queries

  • Clinical Evaluation and Post Marketing Evaluation

 

Key Timelines and Fees: 

Approval timeline: 2 to 3 months 

License validity period: 5 Years

Application Fee: 100 AED 
Registration Feee: 5,000 AED 

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