Device name
Attachment / Required Documents / Availability
A / Application Form
madebythedevice manufacturer or its authorizedrepresentative in C.O.O, signed and stamped by thecompany.
B / RegulatoryApproval
1.Free Sale certificate or certificates, documentation and letters of regulatory approval(legalized by UAE embassy) and C E certification/ clearance to manufacture, sell, import and export the medical device from competent authority in Export country
2.All relevant documents, summary data and objective evidence which have been used to obtain approval or clearance, if available;
C / Post-market requirement / vigilance system and risk assessment)
evidence of establishedprocedures and systems for Distribution Records, Complaint Handling, Adverse Incident Reporting and Recall
D / Status of device distribution
list of countries where it is marketed, details of the regulatory status (e.g. marketing approval, product recall, product ban, etc.) obtained in each country, a summary of the “mandatory” reported problems with the device since the introduction of the device in the market.
E / Device Information:(Enclose Device description & list of models/Codes/Ref No (if any)
  1. Intended Use
  2. Indications
  3. Instructions of Use
  4. Contraindications
  5. Warnings
  6. Precautions
  7. Potential Adverse Events
  8. Device Labeling
  9. Alternative Therapy.
  10. Device labeling which include physicians manual, pack labeling and promotional material
  11. A general description of the device and detailed description of the device attributes; to explain how the device functions, the basic scientific concepts that form the foundation for the device, the component materials and accessories used in its operation as well as packaging. A complete description of each functional component,material/ ingredient of the device should be provided,

F / Labelingsamples
  • Three copies (artwork) of the each product Packaging, labeling and promotional material
  • Sample (if applicable).

G / Declaration of Conformity / Evidence of Conformity to Essential principles
1. Manufacturer’s declaration that the medical device complies with the quality, safety and effectiveness requirements. Any certification to demonstrate this compliance should also be submitted, together with any summary technical files containing objective evidence on the safety and effectiveness of the medical device;
2. Any declaration of product conformity to appropriate product certification. For example, CE mark; Copies of certification and document certifying conformity to appropriate quality systems in production and design(e.g.EC-Design Exam Certificate)/Fill the Checklist appended as Annex 7
H / Safety and effectiveness data
I / Manufacturing Process (pharmaceutical form only)
J / Special requirements for Medical Devices manufactured from or incorporating viable or non-viable animal tissue or their derivative(s).
If devices contain biological materials, copies of documented validated manufacturing processes and certification of appropriate veterinary controls and surveillance adapted to the intended use of the materials;
DRCD Representative Name / Agent/ Company Representative
Signature / Signature
Receipt No. / MD / /201 / Date