Exporting Medical Devices to Saudi Arabia

M

Mor628

#1
Hi all,

Does anyone have experience dealing with export of medical devices to Saudi Arabia?

Our customer from KSA has claimed that, when exporting into KSA, the goods must only come from the country of the legal manufacturer as listed on our ISO 13485 certificate.

Since we are OBL/PLM, our goods come from eg: China, is stored in the Belgium warehouse, before it is shipped to customer in KSA. With our cert saying the legal manufacturer address is UK.

Does that mean we cannot do business with KSA? Our customer claims that if we do not wholly own the China sites and warehouses, our goods will not be allowed in KSA.
 
Elsmar Forum Sponsor

myusoffice

First Time Right...
#2
Hi,

Please check SFDA website for more details:

You may need to get Marketing authorization first then hire a local Authorized representative if manufacturer already doesn't have one, classify your medical device, these all have associated fees and the process can be lengthier.

Hope this is helpful

Regards
Ziaur
 
M

Mor628

#3
Dear Ziaur,

Thanks for your reply. Yes, I have checked their website and also sent an email but nothing has come out of it yet......

We do have Authorized Rep/Distributor in KSA and we are trying to get him to contact SFDA for a clearer answer. Hope that will work

Happy New Year to you :)
 
M

mdalkhen

#4
Dear Mor,
Hope you are doing great, actually I am also staring OBL company to export my products to the middle east, is it possible we can communicate I would like to ask you some information about some papers and documents regarding that.
Regards. .
 
Thread starter Similar threads Forum Replies Date
J Exporting Medical Devices - What is needed from the receiver? Medical Device and FDA Regulations and Standards News 1
C Exporting Demo Medical Devices from USA Other Medical Device Regulations World-Wide 2
E Regulatory Requirements for Exporting Medical Devices to Bonaire EU Medical Device Regulations 1
J Exporting Add-On for Medical Devices to the US - FDA Requirements Other Medical Device Related Standards 3
B Exporting Medical Devices to Kenya Other Medical Device Regulations World-Wide 2
S Pre-Approval Requirements - Exporting Medical Devices to China from the US China Medical Device Regulations 4
N Exporting Class III Medical Devices to Canada from Israel Canada Medical Device Regulations 12
R Requirements for Exporting Class III Medical Devices into the UAE from the US or EU ISO 13485:2016 - Medical Device Quality Management Systems 2
B Requirements for Exporting Medical Devices to Libya Other Medical Device Regulations World-Wide 5
T TGA - Application Fees - Exporting Medical Devices into Australia market Other Medical Device Regulations World-Wide 5
B Requirements for Exporting Medical Devices to Australia Various Other Specifications, Standards, and related Requirements 25
R Exporting to Korea a demonstration only medical device Other Medical Device Regulations World-Wide 2
ScottK Exporting a medical device to Turkey Other Medical Device Regulations World-Wide 2
K Exporting a Class II Medical Device into Kuwait from the US Other Medical Device Regulations World-Wide 3
N ISO 9001 implementation in a Gold exporting business ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
R Exporting to Canada and MDSAP Canada Medical Device Regulations 7
DMLqms Exporting into the EU from UK after Brexit EU Medical Device Regulations 3
S New problems exporting to Germany - February 2019 ISO 13485:2016 - Medical Device Quality Management Systems 7
Edward Reesor Exporting from China - Unified Social Credit Code ISO 13485:2016 - Medical Device Quality Management Systems 2
C Exporting Adult Products from Europe to the United States 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
D Exporting batteries (spare parts) to China China Medical Device Regulations 2
T CE Marking - Exporting replicas (Airsoft) to Europe CE Marking (Conformité Européene) / CB Scheme 1
Q Distributor Contracts and Exporting ISO 13485:2016 - Medical Device Quality Management Systems 2
L GMP (Good Manufacturing Practices) for Wind Turbine Manufacturing and Exporting Other ISO and International Standards and European Regulations 3
Manix Exporting Data from MS Access to MS Word or MS Excel Templates Quality Assurance and Compliance Software Tools and Solutions 5
S Exporting then re-Importing 510(k) device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
B Exporting to and Selling Devices in Spain EU Medical Device Regulations 15
K Requirements for Exporting from US to EU - Class I MD non-sterile, non-measuring EU Medical Device Regulations 7
C Shipping Non-CE products to EU for exporting to other countries CE Marking (Conformité Européene) / CB Scheme 4
Q GeoMeasure 6000 - Exporting buffers to a file Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
A Shipping Validations prior to exporting our product ISO 13485:2016 - Medical Device Quality Management Systems 4
C Exporting Minitab outputs to other programs (Powerpoint)?? Using Minitab Software 5
M Exporting Minitab Data to Excel Excel .xls Spreadsheet Templates and Tools 5
C Exporting Ford's 'FMEA Plus' Files to Excel Excel .xls Spreadsheet Templates and Tools 13
E Medical Device - CE marking - Local market notifications EU Medical Device Regulations 0
S Medical Device Registration in Qatar Other Medical Device Regulations World-Wide 1
B Specialized Medical Apparel Manufacturing and Related Processes 1
B Free Sales Certificate for Non Medical Devices Other Medical Device Related Standards 0
M Medical device substance based-leachables Other Medical Device Related Standards 1
K Usability for custom made medical devices IEC 62366 - Medical Device Usability Engineering 4
P Anyone have an Idea on UAE Medical device registeration- Class B with FDA only Other Medical Device Regulations World-Wide 0
F Mobile app regulations - Class II medical device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M What are the basics of Medical Device Single Audit Program (MDSAP)? ISO 13485:2016 - Medical Device Quality Management Systems 7
dgrainger Informational MHRA - Regulating medical devices in the UK - Post Brexit - 2021-02 UK Medical Device Regulations 0
U Medical Device CE Marking - Using a disposable bearing CE Marking (Conformité Européene) / CB Scheme 3
L Medical Device Registration in Macau Other US Medical Device Regulations 1
A Medical Device Registration in the Dominican Republic Other Medical Device Regulations World-Wide 4
Aymaneh Medical Device Cybersecurity Risk Management IEC 27001 - Information Security Management Systems (ISMS) 2
S Medical watch Class II (AP Type CF) with USB connection IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
T B2C Medical Device Shipping across the US Other Medical Device Related Standards 0

Similar threads

Top Bottom