Importing a Demo Medical Device into the US

M

mghaleb

#1
Hello everyone,

i have a question regarding Import demo medical device into US for Exhobition? must i register the demo device by FDA?

Thank and best Regard,
 
Last edited by a moderator:
Elsmar Forum Sponsor

Mark Meer

Trusted Information Resource
#2
My understanding, is that as long as it is not going to be sold or used for clinical trials, there is no need to deal with the FDA.

Label the device appropriately (e.g. something like "For demonstration purposes only. Not intended for sale or distribution."), and include similar statement/designation on your commercial invoice, and you should be fine.
 
M

MIREGMGR

#3
Note however that "demo" may imply some extent of procedural use. Use in human procedures would not be allowed.

...as long as it is not going to be sold
Sale is not definitive of medical device marketing. Marketing also encompasses free samples, loans, and any other conveyance or provision that results in use in human procedures.
 
Thread starter Similar threads Forum Replies Date
D Importing a general wellness low risk product Other US Medical Device Regulations 3
I Importing prototype without CE (dos and don'ts ) EU Medical Device Regulations 9
S Importing Medical devices class I in EU Other Medical Device and Orthopedic Related Topics 5
O Importing a Medical Device from abroad 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M Importing a Registered Class II Device, the Applying Our Label - Need New 510(k)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
F Mexico Medical Device Importing and Servicing Other Medical Device Regulations World-Wide 2
ScottK Importing medical device for use in fit testing of packaging Other US Medical Device Regulations 3
M Importing medical devices to EU, Germany EU Medical Device Regulations 6
J Requirements for Importing Research Use Only Medical Devices into Japan Japan Medical Device Regulations 1
JanWarner Importing a Finished Medical Device from China (tooth whitener w/ peroxide) China Medical Device Regulations 2
O Importing Data via Script - Assign Column as Text (Minitab) Using Minitab Software 3
W What Information is provided when Importing Products into USA US Food and Drug Administration (FDA) 1
T Importing Non-Electromedical Device (PACS Software) into South Africa Other Medical Device Regulations World-Wide 2
S Importing a DC motor to UK that is less than 50VDC CE Marking (Conformité Européene) / CB Scheme 11
P Requirements for Importing Hydrocolloid Bandages into the US from China Other US Medical Device Regulations 2
Q FDA Registration and Importing Medical Device Components 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
M South Korea Importing Rules for Privately Labeled Medical Devices Advice wanted Other Medical Device Regulations World-Wide 5
N Importing Diagnostic kit from US, UK Other Medical Device Regulations World-Wide 5
B Class I Medical Device Importing for OEM Requirements EU Medical Device Regulations 3
A Importing Sample Medical Devices into South Korea ISO 13485:2016 - Medical Device Quality Management Systems 2
M Importing Material before the 510(k) is Approved 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
M Importing CE marked Syringes Into the US Other US Medical Device Regulations 2
I Importing Medical Devices into the USA from Germany (Drop Shipments) US Food and Drug Administration (FDA) 2
D Importing Class II Male Latex Condoms From China to US Other US Medical Device Regulations 2
L Importing exempt Class I device from non-registered manufacturer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
R Importing Breathalyzers into the USA 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Stijloor Importing Address Books (Thunderbird and Outlook Express) into Windows Live Mail After Work and Weekend Discussion Topics 3
G Importing Medical Device Software to India - Diagnostic Imaging Application Other Medical Device Regulations World-Wide 8
L Importing CSV (comma separated values) / Excel process steps into Visio diagram Excel .xls Spreadsheet Templates and Tools 2
S Exporting then re-Importing 510(k) device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
S Regulations for importing an IVD diagnostic test in India Other Medical Device Regulations World-Wide 16
bio_subbu CDSCO?s checklist on importing non-critical IVD products in India Other Medical Device Regulations World-Wide 1
amjadrana Importing Medical Devices with Computers as part of the device in Turkey Other ISO and International Standards and European Regulations 1
D Medical Device Regulations - Importing to Singapore - Orthodontic brackets Other Medical Device Regulations World-Wide 5
D How to obtain NOC from DCGI (Drug Controller General of India) for importing drugs Manufacturing and Related Processes 6
G Portocal II - Importing procedures Calibration and Metrology Software and Hardware 2
H Regulation in Australia - Importing medical device (class IIa as per MDD 93/42/EEC) ISO 13485:2016 - Medical Device Quality Management Systems 3
C Exporting Demo Medical Devices from USA Other Medical Device Regulations World-Wide 2
N Requirements for the identification and traceability of demo product for sales force US Food and Drug Administration (FDA) 1
S Selling Medical Demo Devices - is it allowable? ISO 13485:2016 - Medical Device Quality Management Systems 2
L Can I ship Demo Units to the UAE if we are not Approved? Other Medical Device and Orthopedic Related Topics 2
T How to handle Demo Units during an ISO 9001 Audit General Auditing Discussions 3
S Logiq Book XP (demo)? Medical Information Technology, Medical Software and Health Informatics 1
C Labeling requirements when selling demo Medical Device equipment 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
AnaMariaVR2 IT Audit: WPA/WPA2 PSK Network Security Demo Software Quality Assurance 0
S Symbol or Label requirements for "Demo Instrument"? ISO 13485:2016 - Medical Device Quality Management Systems 4
Marc SPC Program Demo Statistical Analysis Tools, Techniques and SPC 0
A Any suggestion for a Process Improvement demo Manufacturing and Related Processes 9
S Regrind Material in Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 1
S Iraq Medical Device registration Other Medical Device Regulations World-Wide 0

Similar threads

Top Bottom