DOH GUIDELINES FOR CONDUCTING CLINICAL TRIALS WITH INVESTIGATIONAL PRODUCTS AND MEDICAL DEVICES

Service fees

• Application: 100 AED
• Registration of a medical device: 5,000 AED

Issue of a Certificate of Free Sale of a Medical Product for Export

A serious adverse event is any undesirable experience associated with the use of a medical product in a patient resulting in at least one of the following:
• Death
• Life-threatening condition
• Hospitalization (initial or prolonged)
• Disability or Permanent Damage
• Congenital Anomaly/Birth Defect
• Required Intervention to Prevent Permanent Impairment of a body function or permanent Damage to a body structure.
• Other serious events that do not fit the above outcomes, but may jeopardize the patient and may require medical or surgical intervention (treatment) to prevent one of the above outcomes.

The adverse event has to be mailed to  pv@mohap.gov.ae

For Manufacturers, marketing authorization holders, importers, authorized agents/representatives, distributors, suppliers, registrants, or any person placing the device on the market:

• Deaths, serious injuries, or malfunctions, and events

Marketing Authorization Holder companies and product manufacturing sites must be registered in MOHAP prior to the registration of their products.