Saudi Arabia - Insistence on a signed NB audit report (When one does not exist)

JoshuaFroud

Involved In Discussions
#1
Hello All

I have reached an impasse between my NB and Saudi Arabia. We are looking to place a new device into Saudi and are going through the device registration process. The current sticking point is they are insisting to see a signed copy of our most recent Notified Body audit.

The problem lies in that our notified body send us digital unsigned audit reports. It contains a date, but no signature. We have received a signed letter headed memo from our NB stating that the electronic audit report issued is a complete and full audit report, however as this is a separate document it is not being accepted.

This is the first time I have been involved in Saudi, I was wondering if anyone has any advice?

Side note: sending a full audit report to any outside party seems to go against normal practice. Is this normal for this to be insisted upon during a Saudi registration?

Thanks in advance!

Josh
 
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Sarah Stec

Involved In Discussions
#3
Is this normal for this to be insisted upon during a Saudi registration?
In my experience, it's not surprising. I wrote more than a few letters to SFDA explaining notified body practices in a previous life, on various topics.

Did your NB explain why they wouldn't sign the final audit report (aside from that it's not their practice to do so)?
 

Adele

Involved In Discussions
#4
Medical Device registration in the Kingdom of Saudi Arabia (KSA) is based on the applicant having previously obtained registration in one of the GHTF Founding Member jurisdictions, namely, Australia, Canada, Japan, the USA or the EU. All overseas manufacturers wishing to supply a Medical Device in KSA shall provide the Saudi FDA with documentation that demonstrates that the device is authorized to be placed on the market in one of the 5 markets.
If you use EU as your GHTF market, you will have to supply your EU Notified Body audit report, as well as EC certification and Declaration of Conformity's. The validity period of your registrations can be linked to the validity period of the EC certificate.
This was quite a different request when we first got it but we were unable to negotiate out of it. Nowadays, it has become just one of those things we have to do if we want to sell in KSA. There is always a longer lag between the report and requesting and getting the signed copy.
 
#5
In my past experiences usually a redacted audit report usually works in resolving some of the issues. An explanation letter explaining why a signature is not required from NB and that your device has received clearances/approvals from various agencies world wide may clear this hurdle.
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#8
Please request from NB Z1 form
I did some searches for "NB Z1 form" and, fast as it appeared in the DuckDuckGo search, this thread came up #1. In Google - Nothing... In Bing #2

Is NB Z1 form a Notified Body form? Any further details appreciated.

EDIT ADD: There really ARE differences in search engines. My opinion - Google's search is 'broken'. I use the Duck as my default SEARCH in all of my browsers.
 
Last edited:
#10
Hello All

I have reached an impasse between my NB and Saudi Arabia. We are looking to place a new device into Saudi and are going through the device registration process. The current sticking point is they are insisting to see a signed copy of our most recent Notified Body audit.

The problem lies in that our notified body send us digital unsigned audit reports. It contains a date, but no signature. We have received a signed letter headed memo from our NB stating that the electronic audit report issued is a complete and full audit report, however as this is a separate document it is not being accepted.

This is the first time I have been involved in Saudi, I was wondering if anyone has any advice?

Side note: sending a full audit report to any outside party seems to go against normal practice. Is this normal for this to be insisted upon during a Saudi registration?

Thanks in advance!

Josh
Did you manage to resolve the issue? We have encountered exactly the same issue now with electronic signatures on our NB audit report. In addition, our NB calls it "Assessment Report" which SFDA says is not the same as "Audit Report".
 
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