Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello,

My company wishes to register our IVD products in the Kingdom of Saudi Arabia. 
One requirement is to have a technical documentation available for assessment.
The guideline MDS-G5 says:
Where the manufacturer's claim that its device complies with the
medical device regulations is not subject to premarket review by
the Regulatory Authority (RA), or a Conformity Assessment Body
appointed by the RA to act on its behalf, an indication of the location
of the technical information that supports the manufacturer's claim.
The SFDA may, when duly justified, require the manufacturer to
provide a summary of these documents.

We (have to) use a local representative for the registration. The question is:
Do we need to submit the technical file through the representative, or can we prepare a protected file access (indicate the location) and give direct access to authorities on request?
My understanding is that we do not need to share the technical file with/through the representative company, but how is the actual practice? Does anybody have experiences to share? Do the representative companies in KSA usually request the submission of ("complete") technical documentation to them?

Many thanks!

Hello,

It is mandatory to use local representative for submitting your MD application to SFDA.

Hence, you need to submit them your technical file and on your behalf they will submit to the authority. Protected files may not be a recommended method since your authorized representative has crucial role in registration process and need to know  your technical dossier.

In our case, we had submitted complete MD file to our agent in KSA.

Regards,

------------------------------
Purvi Goradia
Manager Regulatory Affairs
India.
------------------------------

Original Message:
Sent: 28-Jun-2021 07:00
From: Anonymous Member
Subject: KSA technical file access

This message was posted by a user wishing to remain anonymous

Hello,

My company wishes to register our IVD products in the Kingdom of Saudi Arabia.
One requirement is to have a technical documentation available for assessment.
The guideline MDS-G5 says:
Where the manufacturer's claim that its device complies with the
medical device regulations is not subject to premarket review by
the Regulatory Authority (RA), or a Conformity Assessment Body
appointed by the RA to act on its behalf, an indication of the location
of the technical information that supports the manufacturer's claim.
The SFDA may, when duly justified, require the manufacturer to
provide a summary of these documents.

We (have to) use a local representative for the registration. The question is:
Do we need to submit the technical file through the representative, or can we prepare a protected file access (indicate the location) and give direct access to authorities on request?
My understanding is that we do not need to share the technical file with/through the representative company, but how is the actual practice? Does anybody have experiences to share? Do the representative companies in KSA usually request the submission of ("complete") technical documentation to them?

Many thanks!

Hello,

I second Purvi.
The registration file has to be submitted to SFDA portal through your local representative since they will be granted access to the portal.

------------------------------
Youmna Abboud
Beirut
Lebanon
------------------------------

Original Message:
Sent: 28-Jun-2021 07:00
From: Anonymous Member
Subject: KSA technical file access

This message was posted by a user wishing to remain anonymous

Hello,

My company wishes to register our IVD products in the Kingdom of Saudi Arabia.
One requirement is to have a technical documentation available for assessment.
The guideline MDS-G5 says:
Where the manufacturer's claim that its device complies with the
medical device regulations is not subject to premarket review by
the Regulatory Authority (RA), or a Conformity Assessment Body
appointed by the RA to act on its behalf, an indication of the location
of the technical information that supports the manufacturer's claim.
The SFDA may, when duly justified, require the manufacturer to
provide a summary of these documents.

We (have to) use a local representative for the registration. The question is:
Do we need to submit the technical file through the representative, or can we prepare a protected file access (indicate the location) and give direct access to authorities on request?
My understanding is that we do not need to share the technical file with/through the representative company, but how is the actual practice? Does anybody have experiences to share? Do the representative companies in KSA usually request the submission of ("complete") technical documentation to them?

Many thanks!

Hello , 
did you submit your file registration to SFDA , if you need any support , please contact me 

Mona al Moussli 
m.almoussli@pra-me.com 
Regards

------------------------------
Mona Al Moussli
CEO
Dubai
United Arab Emirates
------------------------------

Original Message:
Sent: 28-Jun-2021 07:00
From: Anonymous Member
Subject: KSA technical file access

This message was posted by a user wishing to remain anonymous

Hello,

My company wishes to register our IVD products in the Kingdom of Saudi Arabia.
One requirement is to have a technical documentation available for assessment.
The guideline MDS-G5 says:
Where the manufacturer's claim that its device complies with the
medical device regulations is not subject to premarket review by
the Regulatory Authority (RA), or a Conformity Assessment Body
appointed by the RA to act on its behalf, an indication of the location
of the technical information that supports the manufacturer's claim.
The SFDA may, when duly justified, require the manufacturer to
provide a summary of these documents.

We (have to) use a local representative for the registration. The question is:
Do we need to submit the technical file through the representative, or can we prepare a protected file access (indicate the location) and give direct access to authorities on request?
My understanding is that we do not need to share the technical file with/through the representative company, but how is the actual practice? Does anybody have experiences to share? Do the representative companies in KSA usually request the submission of ("complete") technical documentation to them?

Many thanks!