- Detail of local Distributor
Authorized Distributor
Contact person
Address /Street
City:
Email:: / Tel:
Detail of Drug Store License
No. Of License / Date of Renewal
- Detail of the LOCAL AUTHORIZED REPRESENTATIVE
Name
Address /Street
City / Emirate:
Postal Code
Email: / Tel:
- Detail of the AUTHORIZED REPRESENTATIVE (product’s rights owner) IN COO / MANUFACTURER
Name
Address /Street
City / Country
Postal Code
Email: / Tel:
- Detail of ManufacturING FACTILITY Involoved in the maufacturing
Name of Manufacturing Site / Address /Street / City/Country / Activities occurring at this site
Is the manufacturing facility registered in Registration and Drug Control Department ?
Yes No
If yes, copy of certificates is required If No, the local authorized representative should submit all related documents along with this application
5. Detail of the Device / in vitro dignostic kit
Brand Name / Family Devices
Description
Of the Device
Qualitative and Quantitative composition (In case of Dosage Form)
S.N / Name of Substance / Quantity / Unit / Reference
1
2
3
4
5
6
7
8
Class of the Device
According to the UAE Classification / Class 1 Class 2 class 3 Class 4
Class of the In Vitro Diagnostic / Class A Class B Class C Class D
Type of Device / Active Device Non Active Device Invasive Device Non Invasive Device In Vitro Diagnostic Kit
Description of the rule
Intended use of the device/IVD
Contraindication against use of the device /IVD
User precaution
Disposal/
Environmental Precaution
Cleaning /or Sterilization procedures
(if Applicable)
Performance & Safety
Type summary of risk analysis conducted
(applicable for class 3,& 4)
Type of Test Performance
Storage Conditions
Detail for Safe Handling
Condition to avoid
If applicable
Summary of Clinical Evaluation
(If applicable)
Please tick √ the appreciate box if YES or NO / YES / NO
The device incorporates, as an integral part, a medicinal product which act on the human body with action ancillary to that of the device
The device is manufactured from or incorporating human cells/tissues/ derivatives
The device is manufactured from or incorporating animal cells/tissues/ derivatives
Please specify the classification system of the above mentioned device / In vitro diagnostic Medical Device in other competent authorities if applicable
In case of not applicable, please tick √
GHTF / Class A Class B Class C Class D / Not Applicable
EU / Class 1 Class 2a Class 2b Class 3
Australia / Class 1 Class 2a Class 2b Class AIMD
Japan / Class 1 Class 2 Class 3 Class 4
Canada / Class 1 Class 2 Class 3 Class 4
USA / Class 1 Class 2 Class 3
Singapore / Class 1 Class 2a Class 2b Class 3
China / Class 1 Class 2 Class 3
Taiwan / Class 1 Class 2 Class 3
Malaysia / Class 1 Class 2 Class 3 Class 4
In vitro diagnostic Medical Device
EU / List A List B Self Testing Device / Not Applicable
USA / Class 1 Class 2 Class 3
Canada / Class 1 Class 2 Class 3 Class 4
Japan / Class 1 Class 2 Class 3 Class 4
Others, Please specify:
…………………………………………………………………………………………………………………………………………………………………………………………………………………….
Marketing Approval Status in other countries (please tick √ the appropriate boxes if applicable)
Please attach evidence in registration file
US FDA
○ Pre market Approval
○ Supplementary
○ Investigational Device Exemption
○ 510(k) Clearance
○ Certification for Foreign Government
EU Medical Device Directive(CE Marking)
○ EC Design Examination Certificate
○ EC Type Examination Certificate
○ EC Certificate for quality System/GMP
○Full Quality Assurance system
○ Production Quality Assurance
○ EC Declarations of Conformity
Australia TGA Clearance/Approval
Canada TTP Clearance/Approval
Japan MHLW Clearance/ Approval
Others, Please Specify
…………………………………………………………………………………………………………………………………………………………………………………………………………………….
………………………………………………………………………………………………………….
please tick √ the appropriate boxes
History / Yes / No
The device has been recalled in the country of origin or any country product marketed or in progress?
The device has been revoked/ banned in the country of origin or any country device marketed ?
Has there been any reportable adverse incidents bearing implications to the advice?
Pro-active post market surveillance studies?
Repair & Servicing / Yes / No
The device is intended for single use and non repairable
The device requires regular servicing/testing/checking/calibration
Repairs and servicing provided by local authorized representative or by contracted other party in UAE (if by other party please
Technical support provided by the manufacturer
Declaration Of Conformity (check list)
Submit a written Declaration of conformity states the following:
- That device complies with Conformity assessment elements that include quality, safety and effectiveness requirements.
- conformity to appropriate quality systems in production and design
- Information sufficient to identify the device including its nomenclature
- The name and address of the device manufacturer
- Declaration
We confirm that the information contained in our application is true and correct and that our device are merchantable quality and fir for the purposes for which they are commonly bought.
Signature
Name
Position
Contact telephone
Date