Saudi Arabia - Temperature Storage Requirements

R

RA Princess

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
 
Ronen E

Ronen E

Problem Solver
Moderator
RA Princess said:
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
Click to expand...

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

chris1price

Trusted Information Resource
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
 
S

sreenu927

Quite Involved in Discussions
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
 
O

opigez58

RA Princess said:
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
Click to expand...

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!
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
T Medical Device Registration in Saudi Arabia Other Medical Device Regulations World-Wide 2
J Saudi Arabia Technical File Requirements Other Medical Device Regulations World-Wide 1
T Different Authorized Representative and distributors in Saudi Arabia Other Medical Device Regulations World-Wide 0
M Saudi Arabia (KSA) - Medical Device Vigilance according to 93/42/CEE Other Medical Device Regulations World-Wide 1
C What if the foreign manufacturer of a medical device changes the Authorized Representative in Saudi Arabia? Other Medical Device Regulations World-Wide 0
E Authorized Representative Change - Saudi Arabia Other Medical Device Regulations World-Wide 2
JoshuaFroud Saudi Arabia - Insistence on a signed NB audit report (When one does not exist) Other Medical Device Regulations World-Wide 15
M Exporting Medical Devices to Saudi Arabia Other Medical Device Regulations World-Wide 3
M Is it possible to have more than one authorized representative in Saudi Arabia? Other Medical Device Regulations World-Wide 6
K Saudi Arabia - Renewal of Registration Other Medical Device Regulations World-Wide 1
K One time export to Saudi Arabia: SFDA and MDMA Other Medical Device Regulations World-Wide 2
B Does Saudi Arabia mandate that a CE Mark for a Medical Device is Required? Other Medical Device Regulations World-Wide 10
T FTC "Made In U.S.A" Labeling Rules vs. Saudi Arabia's "Country of Origin" Regulations Other Medical Device Regulations World-Wide 6
T Saudi Arabia and Dubai - Class III Medical Device Regulations? Other Medical Device Regulations World-Wide 15
N Mandatory Language Requirements Saudi Arabia Other Medical Device Regulations World-Wide 14
L Saudi regulations for Japanese non sterile scopes Japan Medical Device Regulations 0
L UDI implementation in Saudi Arabi (KSA) Other Medical Device Regulations World-Wide 1
B Register's Ownership in Iran, India, Jordan, Arab Saudi, Egypt Other Medical Device Regulations World-Wide 8
Colin Does anyone know anything about Saudi Arabian Certification Registrars and Notified Bodies 4
I SFDA (Saudi Food and Drug Authority) and MDMA Registration System Other Medical Device Regulations World-Wide 5
M General Precommisioning Procedure for Saudi Aramco Customer and Company Specific Requirements 4
R New Saudi FDA Rules and Regulation for Medical Devices Other Medical Device Regulations World-Wide 2
S MDDI article on UAE, Saudi, Belarus, Ukraine, Turkey, Russia Regulations Other Medical Device Regulations World-Wide 0
Michael Malis New Saudi FDA Guidelines Other Medical Device Regulations World-Wide 1
S Why does GAGEpack drop the temperature and humidity readings out of the verification event card? Quality Assurance and Compliance Software Tools and Solutions 0
CaliperJim Temperature and Humidity Effects on Measurement Devices General Measurement Device and Calibration Topics 6
H Regarding external surface temperature limit requirement for lab incubators. CE Marking (Conformité Européene) / CB Scheme 2
J Japan registration need manual without temperature reading Japan Medical Device Regulations 0
D Conductivity Water Samples testing temperature Qualification and Validation (including 21 CFR Part 11) 2
J Warehouse temperature and humidity control EU Medical Device Regulations 7
Judy Abbott General temperature used in the blasting process and laser process Manufacturing and Related Processes 2
R IEC 60601-1 - 11.1.3 e) Test criteria - Temperature Measurements IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
T Temperature Requirements For In House Calibration - AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 16
C One Time Service Supplier - Temperature and Humidity Testing Service ISO 13485:2016 - Medical Device Quality Management Systems 5
R SAT (System Accuracy Test) temperature according to AMS2750E AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
W Insulation requirements of BF type infant skin temperature probe IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
B Temperature loop: partial calibration General Measurement Device and Calibration Topics 10
D ASTM C1064 Temperature Measuring Device General Measurement Device and Calibration Topics 2
C ETO Sterilised Class II Medical Device - Required Temperature Storage ISO 13485:2016 - Medical Device Quality Management Systems 1
M Microscope slide warmer temperature control General Measurement Device and Calibration Topics 4
S ISO 18223-2 Temperature symbol in the Legend table in the Instructions for Use Other ISO and International Standards and European Regulations 4
B ASTM F2924-14 /ASTM F3001 - Room temperature classification criteria Other US Medical Device Regulations 1
O Selection of a calibrator (pressure generator, temperature) for my field devices General Measurement Device and Calibration Topics 2
shimonv Symbol for temperature limit EU Medical Device Regulations 6
M Pharmaceuticals Warehouse temperature control (room temperature) Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
T 5ºC Storage Temperature Validation - Urology disposable devices EU Medical Device Regulations 3
Q Weigh Scale Electronics - Suggested Storage Humidity and Temperature Manufacturing and Related Processes 7
M CQI-9 monitoring of temperature in die Various Other Specifications, Standards, and related Requirements 2
C ISO 11607-1 Packaging System - Temperature and shipping conditioning Other Medical Device Related Standards 4
G Calibration Laboratory Dimensional Temperature Question General Measurement Device and Calibration Topics 2

Similar threads

Top Bottom