Adliya Business Centre Co W.

LL - REVIEW REPORT

DOCUMENT NO: Submission date: / /2021

Company : Report Date : / /2021
Status : Second report : / /2021

Company Name:

Registration Type:

Status: Renewal

Client Submission Date: / /2021

Local Client Name:

CR Number: Registration Date: / /

Applicant Name:

Registration certificate number :

Contact No:

Email:

CEO Name:

Address: at CR

S
Document / Section Status Comments/ Suggestions
N
Authorized Sign Stamp Complete Reference
Representative data number
1
Registration variation/
Renewal form
Commercial Registration Number Valid Activity Commercial
(CR) date name
2

3 Company Policies& Procedures

3-A A. Distribution record Signature Stamp Validity date

i) Policy Capture of Record of Policy met NHRA

ii) Capture of system system last month requirement
iii) Record of last

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 Adliya Business Centre Co W.LL - REVIEW REPORT

DOCUMENT NO: Submission date: / /2021

Company : Report Date : / /2021
Status : Second report : / /2021

month

F. Importation Record Signature Stamp Validity date

i) Policy Capture of Record of Policy met NHRA

3-B ii) Capture of system system last month requirement
iii) Record of last
month

K. Service Signature Stamp List of service Capture of

maintenance contact system

i) Policy Record of last Form Policy met NHRA requirement

ii) Capture of the month
3-C system
iii) Form, if not on
system
iv) List of service
contracts with
validity date
P. Field Safety Notice Signature Stamp Validity date Capture of
system
i) Policy
ii) Capture of the Record of Form Policy met NHRA requirement
3-D system last month
iii) Form, if not on
system
iv) Record of last
month, if any
U. Alert & Signature Stamp Validity date Capture of
Modification system

i) Policy Record of Form Policy met NHRA requirement

ii) Capture of the last month
3-E
system
iii) Form, if not on
system
iv) Record of last
month, if any

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 Adliya Business Centre Co W.LL - REVIEW REPORT

DOCUMENT NO: Submission date: / /2021

Company : Report Date : / /2021
Status : Second report : / /2021

Z. Complaint Handling Signature Stamp Validity date Capture of

i) Policy system
ii) Capture of the
system Record of last Form Policy met NHRA
iii) Form, if not on month requirement
3-F system
iv) Record of last
month, if any

EE. Adverse Events Signature Stamp Validity date Capture of

Reporting system

i) Policy List of Form Policy met NHRA

ii) Capture of the adverse event requirement
system (last year)
3-G iii) Form, if not on
system
iv) List of adverse
events from the
previous license
date with final
report
JJ. Recall Signature Stamp Validity Capture of
date system
i) Policy
ii) Capture of the Record of last Form Policy met NHRA
system period requirement
iii) Form, if not on
3-H system
iv) iv) List of recall
from the
previous
license date
with final
report
Storage Main office Outside main Out source
4 office
i) Contract (If out CR copy CR copy

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 Adliya Business Centre Co W.LL - REVIEW REPORT

DOCUMENT NO: Submission date: / /2021

Company : Report Date : / /2021
Status : Second report : / /2021

sourced) Store details/ Store Contrac

ii) CR (If Out capture details t copy
office /out Record Record
sourced) capture capture
List of manufacturers No. of No. of Sign Stamp No. of valid
manufacturer letters letters
5 distribution Authorization
Letters or contracts

Integrated System
6
Company Software
Staff /Service team * No. of staff No. of
(Minimum 3 ) certificate
i) CV s
ii) Qualifications/ submitted
7 Certificates No. of CV No. of
iii) Offer letters submitted offer letter
Biomedical specialist

8 Add new product(s) ~

9 Add new List of Scope
Quality management Sign Valid until certification
system (QMS) body
10 QMS granted to your Authorized
Representative, state the
certification body and its validity +
attachment (if any)
List of locally discarded items
including all the following
information – (Product name,
11 manufacturer
name, Country of origin, batch
number, serial number, quantity,
reason, discarding evidence).
List of returned items to the
manufacturer including all the
following information – (Product
12 name, manufacturer name, Country
of origin, batch number, serial
number, quantity, reason, return
evidence)
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 Adliya Business Centre Co W.LL - REVIEW REPORT

DOCUMENT NO: Submission date: / /2021

Company : Report Date : / /2021
Status : Second report : / /2021

List of supplied medical devices to

13 Health Care Facilities as per the
Permit to Use guideline.
14 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

Reviewed By: / /2021

Revised By: / /2021

Biomedical Engineering Head

Eng. Mohammed O. Ezzat