Adliya Business Centre Co W.

LL - REVIEW REPORT

DOCUMENT NO: Submission date: 08/04/2021

Company : Al Noor Est. for Medical Services Report Date : 09/04/2021
Status : Under process

Company Name: Al Noor Est. for Medical Services

Registration Type: Medical Device Authorized Representative Registration

Status: New registration

Client Submission Date: 08/04/2021

Local Client Name: N/A

CR Number: 23510-2 Registration Date:

Applicant Name: not attach

Contact No: 39434626

Email: alnoor99@batelco.com.bh

CEO Name: : Adnan@alnoormd.com

Address: in CR

S
Document / Section Status Comments/ Suggestions
N
Medical Device Attached Sign Stamp Complete Reference number
Authorized data
1 Representative No No No No
Registration Form Need to use the latest version for AR-Form.
Commercial Registration Number Valid date Acti Commercial name
(CR) Not vity
attached ------------ ------------ ------------
2
-----
----
Attach copy
3 Company Policies& Procedures
A. Distribution record Not Signature Stamp Validity date
attached No No No
3-A i) Policy Capture of Record of Policy met NHRA
ii) Capture of system system last month requirement
iii) Record of last No No No
1
 Adliya Business Centre Co W.LL - REVIEW REPORT

DOCUMENT NO: Submission date: 08/04/2021

Company : Al Noor Est. for Medical Services Report Date : 09/04/2021
Status : Under process

month The policy should submit with procedures and

responsibility as per NHRA regulation.
Attach a capture of system as per NHRA regulation.
Attach record of last month (if available)

B. Importation Record Not Signature Stamp Validity date

attached No No No
i) Policy Capture of Record of Policy met NHRA
ii) Capture of system system last month requirement
iii) Record of last No No No
3-B month  The policy should submit with procedures
and responsibility as per NHRA regulation.
 Attach a capture of system as per NHRA
regulation.
 Attach record of last month (if available)

C. Service Not Signature Stamp Validity date Capture of

maintenance attached system
No No No No
i) Policy Record of last Form Policy met NHRA requirement
ii) Capture of the month
system No No No
3-C iii) Form, if not on  The policy should be attach with procedures
system and responsibility as per NHRA regulation
iv) Record of last  Attach a capture of system as per NHRA
month, if any regulation.
 Attach copy of your service contract
 Attach record of last month (if available)

3-D D. Field Safety Notice Not Signature Stamp Validity date Capture of
attached system
i) Policy No No No No
ii) Capture of the Record of Form Policy met NHRA requirement
system last month
iii) Form, if not on No No No
system  The policy should be attach with procedures
iv) Record of last and responsibility as per NHRA regulation
month, if any  Attach a capture of system as per NHRA
regulation.
 Attach record of last month (if available)
2
 Adliya Business Centre Co W.LL - REVIEW REPORT

DOCUMENT NO: Submission date: 08/04/2021

Company : Al Noor Est. for Medical Services Report Date : 09/04/2021
Status : Under process

E. Alert & Pending Signature Stamp Validity date Capture of

Modification system
No No No No
i) Policy Record of Form Policy met NHRA requirement
ii) Capture of the last month
system No No No
3-E
iii) Form, if not on  The policy should be attach with procedures
system and responsibility as per NHRA regulation
iv) Record of last  Attach a capture of system as per NHRA
month, if any regulation.
 Attach record of last month (if available)

F. Complaint Handling Pending Signature Stamp Validity date Capture of

i) Policy system
ii) Capture of the No No No No
system Record of last Form Policy met NHRA
iii) Form, if not on month requirement
system No Yes No
iv) Record of last  The policy should be completed with
3-F
month, if any procedures and responsibility as per NHRA
regulation
 Attach a capture of system as per NHRA
regulation.
 Attach record of last month (if available)

G. Adverse Events Pending Signature Stamp Validity Capture of

Reporting date system
No No No No
i) Policy Record of last Form Policy met NHRA
ii) Capture of the month requirement
system No Yes No
3-G
iii) Form, if not on  The policy should be completed with
system procedures and responsibility as per NHRA
iv) Record of last regulation
month, if any  Attach a capture of system as per NHRA
regulation.
 Attach record of last month (if available)
3-H H. Recall Pending Signature Stamp Validity Capture of
date system
3
 Adliya Business Centre Co W.LL - REVIEW REPORT

DOCUMENT NO: Submission date: 08/04/2021

Company : Al Noor Est. for Medical Services Report Date : 09/04/2021
Status : Under process

No No No No
i) Policy Record of last Form Policy met NHRA
ii) Capture of the month requirement
system No Yes No
iii) Form, if not on  The policy should be completed with
system procedures and responsibility as per NHRA
iv) Record of last regulation
month, if any  Attach a capture of system as per NHRA
regulation.
 Attach record of last month (if available)

Storage Main office Outside main Out source

Pending office
i) Contract (If out Yes CR copy CR copy No
sourced)
ii) CR (If Out Store Store Contract No
4 office /out details details copy
sourced) /capture
Record Record No
capture capture
 Attach the contract with warehouse world
and the CR of them.
Authorization Letters No. of No. of Sign Stamp No. of valid
Attached manufacturer letters letters
8 8 8 5 4
-Authorization Letters Attached some of them is
expire like:
 MEDIK RUNYES expire (18 July 2020 )
5
 FONA expire (22\7\2020 )
 EURONDA expire (31\12\2020 )
 DIADENT didn’t include validity date.
-Authorization letter of ZHERMACK , EURONDA,
DIADENT,GC EUROPE, RUNYES & GUANGZHOU don’t
include list of product
Integrated System Pending - Attach a capture of your system as per NHRA
6
Company Software regulation.
7 Staff /Service team * Pending No. of staff 11 No. of 0
(Minimum 3 ) certificates
i) CV submitted

4
 Adliya Business Centre Co W.LL - REVIEW REPORT

DOCUMENT NO: Submission date: 08/04/2021

Company : Al Noor Est. for Medical Services Report Date : 09/04/2021
Status : Under process

ii) Qualifications/ No. of CV 5 No. of offer 0

Certificates submitted letter
iii) Offer letters Biomedical specialist Yes
 Need attach offer letter, certificates to your staff as
per NHRA regulation.
Please attach your biomedical Engineering certificate

List of product(s) ~ Attached

8

9 List of Scope Attached

Quality management Sign Valid until certification body
system (QMS) Not
10 QMS granted to your Authorized attached
Representative, state the
certification body and its validity +
attachment (if any)
11 General
Note: This report is based on the evidence and documents provided by the client. Any falsification of
information or violation of NHRA rules will lead to cancellation of registration.

Recommendation:

Engineer Name Signature Date

Eng / Ghada Zahran
Reviewed By: 9 / 04 /2021

Revised By: Eng. Nabil Dawidar / /2021

Biomedical Engineering Head

Eng. Mohammed O. Ezzat