# Question

1 You should have in your store

2 Fire extinguisher, Is it from inspection elements?
3 If you are new AR, you should submit ……
4 Is it mandatory to submit a valid license from the Council for Regu
5 It prevents loss in production by reducing chances of failure occur
6 Incase of recall after withdraw, you need to put the recalled device
7 Who is responsible to communicate with NHRA?
8 Is the qualification from the essential parameters to scoring AR co
9 In case of AR license process, post Initial approval, applicant wil
10 What is the evidence of destruction in Bahrain?
11 It is strictly recommended that below must have a PMS Officer
12 Who must attend the inspection?
13 During the inspection if the provided documents are incorrect, the in
14 From where you know the HS code of the device?
15 If you add new scope, you should…
16 Importation requests is recommended to be submitted on OFOQ by
17 Incase AR registration, Minimum number of required employee’s
18 If the store is in outsource, what is required from your side?
19 In case Bahrain market is affected by FSN, End users’ acknowledgm
20 Authorization letter gives AR responsibility to…..
21 Who will report for job order or device failure?
22 If you have many branches, you should have each PMO for each br
23 Should you get pre-approvals from OFOQ after the shipment arrives
24 If you have many branches, you should have each RAO for each br
25 What is the duration of the AR license?
26 If you return the device to manufacturer, the announce was….
27 In case Bahrain market is not affected by FSN, a letter to be provid
28 Disposing of active medical devices without reporting to NHRA lead
29 In case of adding a new branch of the same AR, applicant should su
30 What is the action required in case of Recall?
31 Who will issue FSN?
32 If you implement FSCA, the announce was….
33 For new companies, in case of changing scope of service in the fina
34 Medical device activity code in CR is ____
35 Who can report Complaint Handling?
36 License from CRPEP should be provided for all staff?
37 In case of High Risk FSN, a copy of the notice must be provided to
38 Corrective Maintenance is performed ….. device failure or after an
39 Policies for AR registration should contain ……..
40 Can AR merge two software during registration?
41 Incase AR registration, Training certificate can be submitted instead
42 Importation request should be submitted on OFOQ by ……..
43 Is it applicable to submit employment contract instead of offer lett
44 My software should record reports of medical device (Reporting, F
45 Incase AR registration, Should Authorized Representative have an
46 If you destruct the device, the announce was….
47 Who can report Alert & Modification?
48 Incase AR registration, List of scope service has limit to submit
49 If NHRA announce for FSN you need to confirm within …… days
50 Is the license from CRPEP mandatory for Biomedical engineer?
51 Which of below requirement is essential for Store Outside Main off
52 In case of Death / Serious injury adverse event, what is the timef
53 Quality management system refer by ISO……
54 The authorized representative will be listed in restricted list in custo
55 Providing Misleading information lead to ….
56 Incase AR registration, Authorization letter should be issued by …….
57 Is the storage from the essential parameters to scoring AR compan
58 In case of Moderate Risk FSN, a copy of the notice must be provid
59 Quality Assurance Certificate (CE) / foreign government FDA shoul
60 Action taken incase of FSN….
61 Medical devices are not transported as per manufacturer recommen
62 When I should apply for renewal AR license?
63 In case of Problems not associated with high risk or injury advers
64 All medical devices with the HS code listed under ministry code…
65 Storing expired items mixed with new items lead to ….
66 Can you apply capture of system as an Excel?
67 Updating the commercial address of the establishment after issuing t
68 Shipment sent to Bahrain …… getting pre-approval
69 Inspection will be done ….. Get initial approval
70 Incase AR registration, Is it mandatory to have “Service maintenanc
 Student Dashboard
A
Quarantine area
Yes
CR with activity
Yes
Corrective maintenance
In-Area
AR
Yes
1
Invoice of destruction
Importer
All authorized representative staff
Yes
Invoice
Submit for variation
Yes
2
Valid CR for the store
1 month starting from the date of confirmation
Register
Manufacturer
Yes
Yes
Yes
One year
FSN
1 month starting from the date of confirmation
Variation
Yes
Destruction in Bahrain
Manufacturer
FSN
Yes
651
Manufacturer
Yes
2 working days
After
Effective date
Yes
Yes
Authorized Representative
Yes
Yes
Yes
FSN
Manufacturer
Yes
 5
Yes
NHRA License
2 working days
13485
1
Variation
Legal Manufacturer
Yes
2 working days
Legal Manufacturer
Destruction
Variation
3 months before expiry date
10 working days
2551
Variation
Yes
Accepted
After
After
Yes
 Student Dashboard
B
In/out area
No
Application number from Sijilat
No
Periodic preventive maintenance
Out-Area
CEO
No
3
Air way bill
Health Care Facility
CEO only
No
Catalogue
Wait until renew license
No
3
Storage Record Capture
1 week starting from the date of confirmation
Import
End-user
No
No
No
3 years
Recall
1 week starting from the date of confirmation
Violation
No
Return the defected medical device to the manufacturer
NHRA
Recall
No
4659
NHRA
No
5 working days
Before
Revision date
No
No
Clearance agent
No
No
No
Recall
NHRA
No
 3
No
ISIC4 code 4659
5 working days
9001
2
Violation
Physical Manufacturer
No
5 working days
Physical Manufacturer
FSCA
Violation
6 months before expiry date
20 working days
2251
Violation
No
Not accepted
Before
Before
No
C D Correct Answer
Expired/damage area All the above D
A
B
A
B
Quarantine Area C
A
A
6 9C
Both A & B A
Both A & B C
Authorized representative employee only A
B
Any one of them A
A
A
5 B
Contract All the above D
3 days starting from the date of notifying AR A
Sell All the above D
NHRA B
B
B
A
5 years A
Complaint B
3 days starting from the date of notifying AR A
Renewal B
A
Any one of them C
Any Regulatory Authority All the above D
Complaint A
A
3586 3645 B
End-user All the above C
B
10 working days B
A
Both a&b C
A
B
A
A
A
A
Complaint B
Any Regulatory Authority All the above A
B
 10 B
A
A
10 working days C
14001 A
3 4C
Renewal B
Any one of them A
A
10 working days C
Any one of them A
Return to manufacturer B
Renewal B
1 month before expiry date B
30 working days C
2511 B
Renewal B
B
B
During A
During A
B
User Anwser Result
D Correct
A Correct
A Wrong
A Correct
B Correct
C Correct
A Correct
A Correct
C Correct
C Wrong
C Correct
A Correct
B Correct
A Correct
A Correct
A Correct
B Correct
D Correct
C Wrong
D Correct
B Correct
B Correct
B Correct
A Correct
A Correct
B Correct
A Correct
B Correct
A Correct
C Correct
D Correct
A Correct
B Wrong
B Correct
C Correct
B Correct
A Wrong
A Correct
C Correct
B Wrong
A Wrong
A Correct
A Correct
A Correct
A Correct
B Correct
D Wrong
B Correct
B Correct
A Correct
A Correct
B Wrong
A Correct
C Correct
B Correct
A Correct
A Correct
C Correct
A Correct
B Correct
B Correct
A Wrong
A Wrong
B Correct
B Correct
B Correct
A Wrong
A Correct
A Correct
A Wrong