Medical device registration in UAE
Regulatory Authority:
Drug control department (DCD)
Classification:
I, II, III, IV
AUTHORIZED REPRESENTATIVE: An authorized representative is required to register medical devices in the UAE.
How to register for your medical devicein UAE Classify as first step
Documents required:
Authenticated copies of certificates relating to governmental approval of the device’s manufacturing facility in the country of origin.
Copies of all certificates, documentation and letters of regulatory approval/clearance to manufacture, sell, import and export the medical device.
Evidence of established procedures and systems for distribution records, complaint handling, adverse incident reporting and recall.
Product and production information, such as manufacturing process and facilities information, device description, specifications of materials used in manufacturing and packaging, intended use and instructions for use, indications and contraindications, warnings and precautions, potential adverse events, alternative therapy, device labeling, shelf-life stability, animal/human tissue content.
Copies of certification and documentation certifying conformity to product standards, safety and effectiveness requirements, and quality systems in design and manufacturing.
Date of first introduction and use, list of countries where device is marketed and details of corresponding regulatory status, and a summary of reported problems with the device since introduction.
Risk assessment comprising of risk analysis, evaluation and reduction measures, and detailed information on safety and effectiveness studies, including pre-clinical and clinical studies, process validation studies, software validation studies where appropriate, and literature studies, with summary of studies, conclusions drawn from those studies and bibliography of published reports dealing with the device.
Objective evidence on the biological safety of the device.
Peer-reviewed scientific literature dealing with the device.
Price information, including ex-factory price, wholesale price in the country of origin, and retail price in the country of origin.
The registration or listing will be valid for five years or until suspension or revocation by the authorities or termination of the listing.
The validity of the registration shall be subjected to:
Submission of biannual post-marketing surveillance reports for products defined by the Drug Registration and Control Department (DR & CD) to have high potency or requirement of special attention.
Submission of adverse effects reports associated with device usage (applicable for pharmaceutical products under classes 3 and 4 invasive and implantable medical devices).
Documents required:
Authenticated copies of certificates relating to governmental approval of the device’s manufacturing facility in the country of origin.
Copies of all certificates, documentation and letters of regulatory approval/clearance to manufacture, sell, import and export the medical device.
Evidence of established procedures and systems for distribution records, complaint handling, adverse incident reporting and recall.
Product and production information, such as manufacturing process and facilities information, device description, specifications of materials used in manufacturing and packaging, intended use and instructions for use, indications and contraindications, warnings and precautions, potential adverse events, alternative therapy, device labeling, shelf-life stability, animal/human tissue content.
Copies of certification and documentation certifying conformity to product standards, safety and effectiveness requirements, and quality systems in design and manufacturing.
Date of first introduction and use, list of countries where device is marketed and details of corresponding regulatory status, and a summary of reported problems with the device since introduction.
Risk assessment comprising of risk analysis, evaluation and reduction measures, and detailed information on safety and effectiveness studies, including pre-clinical and clinical studies, process validation studies, software validation studies where appropriate, and literature studies, with summary of studies, conclusions drawn from those studies and bibliography of published reports dealing with the device.
Objective evidence on the biological safety of the device.
Peer-reviewed scientific literature dealing with the device.
Price information, including ex-factory price, wholesale price in the country of origin, and retail price in the country of origin.
The registration or listing will be valid for five years or until suspension or revocation by the authorities or termination of the listing.
The registration or listing will be valid for five years or until suspension or revocation by the authorities or termination of the listing.
The validity of the registration shall be subjected to:
Submission of biannual post-marketing surveillance reports for products defined by the Drug Registration and Control Department (DR & CD) to have high potency or requirement of special attention.
Submission of adverse effects reports associated with device usage (applicable for pharmaceutical products under classes 3 and 4 invasive and implantable medical devices).
Titansmedical can help you with medical device or IVD registration, act as your Authorized representative and support you with distributor identification and importation.
