# Question

1 All of the following is correct regarding AR registration except:

2 The CVs of at least two employees should be submitted during AR r
3 AR licence has a validity of.....
4 Submitted authorization letters during AR renewal are directly associ
5 NHRA Pharmacy & Pharmaceutical Products Regulation (PPR) license is
6 Which of the following is required during AR inspection
7 The last step during AR registration to grant the final approval of med
8 Copy from the corrosponding ..... should be submitted in case of AR
9 AR renewal and variation can be submitted in one application duri
10 AR tracing system (software) should have the full records of .....
11 Only medical devices importers should obtain AR license
12 Which of the following is not mandatory requiremnt during AR regi
13 AR license variation applications are submitted through ...... system
14 For AR registration, which of the following is mandatory in case of o
15 During AR registration process, the applicant should prepare the facil
16 It is mandatory for AR to display the working hours of the establish
17 All of the following falls under AR variation service except:
18 Authorization letters from medical devices manufacturers is not re
19 The AR can use Excel sheets as a replacment of the tracing system
20 The applicant should submit AR renewal application before ..... mon
 Student Da
A
The applicant should submit captures from the used tracing system(
True
1 year
AR tracing system
True
Labeling for the products
Submit AR license on Ajheza
Storage records
True
Importation
True
Tracing system (software)
Ajheza
Copy from the CR of the storing facility
1 month
True
Changing the commercial address of AR office
True
True
1 month
 Student Dashboard
B
The applicant can resubmit the new AR registration application up t
False
2 years
AR scopes
False
Fire extinguisher available and maintained
Submit AR license on Sijilat
Tracing system (software)
False
FSN & Recall
False
List of employees for medical devices and their qualification
Sijilat
The contract agreement with the storing facility
6 months
False
Recall medical device to the manufacturer
False
False
3 months
Dashboard
C
After receiving the AR license, the applicant should attach the licens

3 year
AR forms

Tracing system (Software). including LOT no., Batch no., Serial no. ,
Both A and B
Authorization letter/s

Both A and B

Quality management system (QMS) for the Authorized representat

Both A and B
Copy from NHRA license of the storing facility
6 weeks

Changing storing facility type

6 months
D Correct Answer User Anwser
ARs are classified into four classes: Class A, B, C, and D B B
B B
4 years A A
None of the above B B
A A
All of the above D D
None of the above B B
Sijilat capture C C
A A
None of the above C C
B B
Policies & procedure C C
None of the above A A
A and B D D
1 week B B
A A
Adding new scopes B B
B B
B B
None of the above C B
Result
Correct
Correct
Correct
Correct
Correct
Correct
Correct
Correct
Correct
Correct
Correct
Correct
Correct
Correct
Correct
Correct
Correct
Correct
Correct
Wrong