Saudi Arabia - Temperature Storage Requirements

R

RA Princess

#1
Can anyone help. We have been told by the Saudi Distributor that any order shipping to Saudi Arabia should comply with the following:
- all medical devices should ship with temperature indicator (temperatures asper product label), each pallet or box in the shipment must contain temperature indicator (data logger) activated from the time of shipping

The devices that are going to be shipped are long standing devices that have been available on the market for over ten years and do not have specific storage requirements defined. Has anyone been in the same position and have had to label the devices with storage limits in order to comply?

Thanks
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Can anyone help. We have been told by the Saudi Distributor that any order shipping to Saudi Arabia should comply with the following:
- all medical devices should ship with temperature indicator (temperatures asper product label), each pallet or box in the shipment must contain temperature indicator (data logger) activated from the time of shipping

The devices that are going to be shipped are long standing devices that have been available on the market for over ten years and do not have specific storage requirements defined. Has anyone been in the same position and have had to label the devices with storage limits in order to comply?

Thanks
This can be a newly introduced requirement.

For a given device, not having specific storage requirements is not the same as stating that it's indifferent to storage conditions, or at least to the expected range of storage conditions.

To avoid attaching the indicator and/or logger, you might try to proactively assess the foreseeable extreme conditions along the supply route (up to end user) and declare that the product is immune to those conditions. You might then have to validate that claim.

I don't know what the device is, but a product warehoused in an uncontrolled environment in Saudi Arabia during summer can easily get exposed to temperatures of 100C and more. Have your devices been on the Saudi market for years?

Cheers,
Ronen.
 

chris1price

Trusted Information Resource
#3
Hi, looking at the SFDA "Medical and IVD Devices Clearance Requirements Version 3.0" from 2014, they say:

11. For Medical Devices IVD’s, Each Pallet in the shipment must contain temperature indicator activated from the time of shipping.

12. For Medical Devices that require specific transportation and storing temperatures, Each Pallet in the shipment must contain temperature indicator activated from the time of shipping.

However, there may be more recent requirements. I agree with Ronen that temperatures can be extreme and not having an upper limit may leave you open to questions.

Chris
 

sreenu927

Quite Involved in Discussions
#4
Is the medical device registered with Saudi FDA? If yes and If you don't have any special storage conditions for your medical devices, then you can provide a declaration letter to your distributor for him to notify the Saudi FDA.
If not, while registering you can provide the same declaration/justification letter.

Regards,
Sreenu
 
#5
Can anyone help. We have been told by the Saudi Distributor that any order shipping to Saudi Arabia should comply with the following:
- all medical devices should ship with temperature indicator (temperatures asper product label), each pallet or box in the shipment must contain temperature indicator (data logger) activated from the time of shipping

The devices that are going to be shipped are long standing devices that have been available on the market for over ten years and do not have specific storage requirements defined. Has anyone been in the same position and have had to label the devices with storage limits in order to comply?

Thanks
Intertec is the company offering the verification for such shipment and make sure to provide the letter fo conformity so you can avoid all of these issue:usg shipping to saudi arabia
Any morre contact intertck or USG!
 
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