# Question

1 The official relationship letter from legal manufacturer can include

2 In case of system bundling, the products can be for different risk cla
3 In case of the QAC Certificate is not issued from a recognized certify
4 ISO 13485:2016 certificate is considered as QAC certificate
5 Who is the issuer of the authorization letter?
6 Incase the medical device is subjected to caused a minor adverse e
7 In case of renewal of any certificate, it will be considered as ….. var
8 The address in IFU should match with the address in …
9 Contact lens with the same size and different color are bundled as
10 Do you need classification letter if your product is dialysis solution?
11 Who is the issuer of the list of countries?
12 It's not mandatory for QAC certificate to include List of device/Sco
13 If there are FSN records affecting Bahrain market, you should get off
14 In case of changing the address of legal manufacturer, it will be co
15 The notifying body who issue the QMS certificate, it should be m
16 If I change the price of medical device, I need to submit for variati
17 In case of family bundling application, you should submit the artwo
18 Surgical instruments with the same intended use are example for…
19 Gloves with different material are example on similar bundling
20 Category A incase renewal is for Certificates issued after October 2
21 The issuer of Declaration of conformity (DOC) is ….
22 The notifying body who issue the QAC, it should be member at …..
23 In case of Adding IVD medical device to a registration license if dif
24 In case you have authorization letter from the regional authorized
25 During preparing the listing, you need to mention devices you need
26 I have registered software system (as a medical device)and I update
27 Incase of major variation, MDR license will be valid
28 In case of changes in the instruction for use, it will be considered as
29 Switzerland is considered as reference country
30 If there is change in the reference number, it will be major variatio
31 If the products with same legal manufacturer, brand name, risk cla
32 Standard of QMS certificate is …..
33 Applicant can submit Declaration of Conformity instead of QAC inca
34 You should attach all MDR registration requirements incase of cate
35 All healthcare facilities will be instructed to purchase only…..
36 In case of renewal of official letter, it will be considered as ….. varia
37 In case of IVD bundling, the products should be same risk classifica
38 Are electronic signature and Electronic stamp accepted in all official
39 If the software is classified as a medical device, it should be regist
40 It's mandatory to attach New artwork only incase of Manufacturer
41 In case of changing design or detailed specification of the device, i
42 In case you have authorization letter from the regional authorized
43 In case of procedure pack bundling, the products shouldn't exceed
44 Who Is the issuer of list of End-user?
45 Declaration of conformity (DOC) should include …..
46 Incase of minor variation, MDR license will be cancelled
47 If the device was marketed in Bahrain for minimum 3 years, the of
48 Technical details issued by..........
49 If there is renewal for the Quality Assurance certificate (QAC), it wi
50 What is the validity of E-mail you attached for verification the qualit
51 Who is the holder of Quality management system (QMS)?
52 Free Sale Certificate is required for Manufacturer Acquisition
53 In case of changes made to the authorized representative details, it
54 If the device wasn’t marketed in Bahrain for minimum 3 years, the
55 EC Design examination certificate is mandatory for class III medical
 Student Dashboard
A
Physical manufacturer
True
Accepted
True
Legal Manufacturer
True
Minor
Relationship letter
Similar
True
Legal Manufacturer
True
NHRA medical device post market department
Minor
True
True
True
Similar
True
True
Legal Manufacturer
IAF
True
True
True
True
True
Minor
True
True
Similar
ISO 13584:2016
True
True
Registererd medical devices
Minor
True
True
True
True
Minor
One Authorization letter
5
Legal Manufacturer
Risk classification
True
True
Legal Manufacturer
True
3 months
Legal Manufacturer
True
Minor
True
True
 Student Dashboard
B
Regional authorized distributer (Optional)
False
Rejected
False
Physical Manufacturer
False
Major
Artwork
Family
False
Physical Manufacturer
False
Legal manufacturer
Major
False
False
False
Family
False
False
Physical Manufacturer
NANDO
False
False
False
False
False
Major
False
False
Family
ISO 13485:2016
False
False
All medical devices
Major
False
False
False
False
Major
Two Authorization letter
15
Physical Manufacturer
GMDN code
False
False
Physical Manufacturer
False
6 months
Physical Manufacturer
False
Major
False
False
C D
Sub distributer in Bahrain (AR) (Optional) All the above

classification letter
System Procedure pack

Authorized representative

Both

System Procedure pack

Regulatory Authority
Both

System Procedure pack

ISO 13485:2019

25 50
Authorized representative
Both

Notifying body NHRA

9 months
Both
Correct Answer User Anwser Result
D D Correct
A A Correct
B B Correct
B B Correct
A A Correct
B B Correct
A A Correct
B B Correct
A A Correct
A A Correct
A A Correct
B B Correct
C C Correct
B B Correct
B B Correct
B B Correct
A A Correct
B D Wrong
B B Correct
A A Correct
A A Correct
B B Correct
B B Correct
B B Correct
B B Correct
A A Correct
B B Correct
A A Correct
A A Correct
B B Correct
A A Correct
B B Correct
A A Correct
B B Correct
A A Correct
A A Correct
A A Correct
A A Correct
A A Correct
B B Correct
B B Correct
B B Correct
D D Correct
C C Correct
C C Correct
B B Correct
B B Correct
A A Correct
B B Correct
A A Correct
B B Correct
A A Correct
A A Correct
B B Correct
A A Correct