Exporting to Korea a demonstration only medical device

R

RKUB38

#1
Hi,
does someone know if we can export a medical device (class I and II) to Korea that is no approved, for demonstration purpose only?
thank you very much!
 
Elsmar Forum Sponsor

edgar123

Starting to get Involved
#2
Hello, yes it's possible. As you might guess there are strict requirements for labeling ("not for sale") and the safety of the device has to be demonstrated.
 
Thread starter Similar threads Forum Replies Date
R Exporting to Canada and MDSAP Canada Medical Device Regulations 7
J Exporting Medical Devices - What is needed from the receiver? Medical Device and FDA Regulations and Standards News 1
DMLqms Exporting into the EU from UK after Brexit EU Medical Device Regulations 3
C Exporting Demo Medical Devices from USA Other Medical Device Regulations World-Wide 2
S New problems exporting to Germany - February 2019 ISO 13485:2016 - Medical Device Quality Management Systems 7
E Regulatory Requirements for Exporting Medical Devices to Bonaire EU Medical Device Regulations 1
Edward Reesor Exporting from China - Unified Social Credit Code ISO 13485:2016 - Medical Device Quality Management Systems 2
M Exporting Medical Devices to Saudi Arabia Other Medical Device Regulations World-Wide 3
C Exporting Adult Products from Europe to the United States 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
ScottK Exporting a medical device to Turkey Other Medical Device Regulations World-Wide 2
J Exporting Add-On for Medical Devices to the US - FDA Requirements Other Medical Device Related Standards 3
D Exporting batteries (spare parts) to China China Medical Device Regulations 2
B Exporting Medical Devices to Kenya Other Medical Device Regulations World-Wide 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
S Pre-Approval Requirements - Exporting Medical Devices to China from the US China Medical Device Regulations 4
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
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
K Exporting a Class II Medical Device into Kuwait from the US Other Medical Device Regulations World-Wide 3
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
T TGA - Application Fees - Exporting Medical Devices into Australia market Other Medical Device Regulations World-Wide 5
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
B Requirements for Exporting Medical Devices to Australia Various Other Specifications, Standards, and related Requirements 25
C Exporting Ford's 'FMEA Plus' Files to Excel Excel .xls Spreadsheet Templates and Tools 13
D Has anyone had sudden challenges from Korea-MFDS? Other Medical Device Regulations World-Wide 1
S Medical Device Product Classification in South Korea Other Medical Device Regulations World-Wide 1
C Can a manufacturer (in South of Korea) have multiple Brazil Registration Holder (BRH) for same brend name? Other Medical Device Regulations World-Wide 1
E South Korea, MFDS - GMP inspections Other Medical Device Regulations World-Wide 4
J South Korea, MFDS - Medical Device Change Management Other Medical Device Regulations World-Wide 5
S Adverse Event and Serious Adverse Event Reporting - Korea Other Medical Device Regulations World-Wide 4
Y List of Cell therapy and Gene Therapy products in South Korea and China Other Medical Device and Orthopedic Related Topics 1
H Korea DMF (Drug Master File) Fees Various Other Specifications, Standards, and related Requirements 5
shimonv Korea License Holder for a Medical Device Medical Information Technology, Medical Software and Health Informatics 4
R Immigration permit for countries such as Korea Immigration and Expatriate Topics 4
S Korea - MFDS (South Korea Ministry of Food and Drug Safety) Contact? Other Medical Device Regulations World-Wide 4
E Number of medical device clinical trials has reduced by 20% in Korea Other Medical Device Regulations World-Wide 1
E Korea Medical Device License Holder FAQ Other Medical Device Regulations World-Wide 1
E Medical Device Distribution Quality Management in South Korea Other Medical Device Regulations World-Wide 0
U Language requirements - Software interface - Japan and South Korea Japan Medical Device Regulations 4
pittmatj South Korea - Custom Medical Device Regulations Other Medical Device Regulations World-Wide 1
S South Korea Ultrasound Software Requirements Other Medical Device Regulations World-Wide 1

Similar threads

Top Bottom