Exporting a medical device to Turkey

ScottK

ScottK

Not out of the crisis
Staff member
Super Moderator
#1
#1
We (in the USA) have been asked by a Turkish company to design and make a device that is identified as Class I in the US and EU for them as a contract manufacturer, and ship directly to Turkey.

What is our regulatory responsibility as far as Turkish requirements since the Turkish company is the legal manufacturer?
 
Standard Work Instruction Software by Dozuki
Elsmar Forum Sponsor
J

john ambrose

#3
#3
I work with integrated circuits, so, I can tell you what we do for export. First, check what your system would be considered by the Bureau of Industry and Security and check to see if it is EAR 99 or has a Export Control Classification Number (ECCN). You can get the descriptions at bis.doc.gov.

Next, you want to do your best to make sure your customer in Turkey is not going to ship to an embargoed country. We have our potential customers sign a document placed on their letterhead making sure they know that certain countries cannot receive our products. There are exceptions that your product may fit into, but, this requires more paperwork and I am not familiar with that process.

The key thing for the BIS is you don't "self blind". Ask the questions, be happy with the answers, document, and it should go well for you.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
R Exporting to Korea a demonstration only medical device 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
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
M Exporting Medical Devices to Saudi Arabia Other Medical Device Regulations World-Wide 3
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
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
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 2
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
M Medical Device Registration In Malaysia Other Medical Device Regulations World-Wide 2
N Adding unclassified product to the medical device registration US Food and Drug Administration (FDA) 1

Similar threads

Top Bottom