Scientific and Research Papers for Foreign Approved Devices

fialor

Involved In Discussions
#1
Hi All,

Could anyone help please.

I am looking for guidance on what can be shared at an exhibition including web publication for medical devices with foreign approval which are not manufactured in the USA.

I have found a guidance on devices approved but with new uses but this is silent on the question above.

Thanks for your help.

Fialor
 
Elsmar Forum Sponsor

shimonv

Trusted Information Resource
#2
Hi Fialor,
You are asking a very broad question and therefore I can only offer a broad answer:
- Check the content for any false or misleading claims.
- Beware not promote any off-label use.
- I would avoid web publication because their credibility is doubtful.
- You may want to put a stamp on the printed material stating that the device / indications is not approved in the local market.


Good luck,
Shimon
 
Thread starter Similar threads Forum Replies Date
K Exemption from Section 7 clauses of ISO 9001 - Scientific Research Company Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
K Validation of Processes does not seem to apply - Scientific Research Company Design and Development of Products and Processes 1
R Scientific Operating Procedures For Sterilization Practices in India PSA/2012/1 Other Medical Device Regulations World-Wide 0
M Medical Device News Health Canada - Scientific Advisory Panel on Software as a Medical Device (SAP-SaMD) - Record of Proceedings – January 26, 2018 Canada Medical Device Regulations 0
Marc NIST’s Trove of Scientific Instruments and Relics After Work and Weekend Discussion Topics 2
arios Scientific evidence against the existence of Santa Claus Funny Stuff - Jokes and Humour 21
V Scientific Expedition Brain Teasers and Puzzles 3
P Koslow Scientific Metal Test Kit - Control and Calibration Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
H Exponent in Excel .xls - How can I make the result typical scientific notation? Excel .xls Spreadsheet Templates and Tools 27
L Clinical research - Request from ANVISA ISO 14971 - Medical Device Risk Management 1
Watchcat Authoritative References about the Research Question? Quality Tools, Improvement and Analysis 0
A VDmax25 and cGMP requirements for "research use only" products Other Medical Device Related Standards 1
M Risk Classification For Supplier - Clinical Research Organisation (CRO) Supply Chain Security Management Systems 3
M Exemption Clauses for Research, Demonstration, etc. Other Medical Device Regulations World-Wide 2
N Time source for paper-based documentation (research nurses) US Food and Drug Administration (FDA) 1
M Medical Device News CDRH Research Programs – VICTRE: Virtual Imaging Clinical Trials for Regulatory Evaluation Medical Device and FDA Regulations and Standards News 0
S Medical Device Research Use Only (RUO) label Other Medical Device Regulations World-Wide 4
M Acceptance of remote auditing techniques - Can you help me with my research? General Auditing Discussions 0
N Dataset for Academic Research - Infusion pump flow IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
T Research Medical Device EU - Requirements and Regulations EU Medical Device Regulations 13
Y Change Management in a very complex Research Organization Misc. Quality Assurance and Business Systems Related Topics 3
L EU MDR CRO (Contract Research Organization) requirements for Clinical Investigations EU Medical Device Regulations 1
T Control of R&D (Research and Development) Parts and Equipment ISO 13485:2016 - Medical Device Quality Management Systems 3
I AS9100D - Interview Request - I'm doing research Misc. Quality Assurance and Business Systems Related Topics 1
I Design & Development, Research and Innovation in the Medical Device framework ISO 13485:2016 - Medical Device Quality Management Systems 3
R University Research Project - Management Review Management Review Meetings and related Processes 17
H Research Use Only (RUO) Medical Devices in China China Medical Device Regulations 7
S Does a Research facility require DEA registration ? Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
T Early Research & Development - ISO 13485:2003 requirements Clarification ISO 13485:2016 - Medical Device Quality Management Systems 34
Q IEC 60601 for Non-Medical Research Purpose Devices IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
C Selling of Research products in Europe EU Medical Device Regulations 9
Q RUO (Research Use Only) vs. IVD (In Vitro Diagnostic) - Differences EU Medical Device Regulations 6
J Requirements for Importing Research Use Only Medical Devices into Japan Japan Medical Device Regulations 1
E Research or other consents missing from the Donor Medical Chart Document Control Systems, Procedures, Forms and Templates 5
I Is ARIMA (Time Series Analysis) Model appropriate for this Dental Research? Using Minitab Software 4
W Question on Research Use Only (RUO) products into Indonesia, Philippines and Thailand Other Medical Device Regulations World-Wide 2
J Research Use Only for an MD/IVD Kit EU Medical Device Regulations 3
AnaMariaVR2 FDA's Research Strategic Plan (RSP) US Food and Drug Administration (FDA) 0
W FDA Regulations for Research and Development US Food and Drug Administration (FDA) 10
C Should Research Findings be in the Design History File? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
G R&D (Research and Development) & Workorder Formats Document Control Systems, Procedures, Forms and Templates 2
J Research Use Only (RUO) for Non IVD in EU EU Medical Device Regulations 5
T Class I Medical Device for use in a research project by a physician in Spain 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
J EDMS for Very Early Drug Development (Research/Drug Discovery) Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 4
H Medical Device RUO (Research Use Only) and 'Sterile' Label Claims 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
J Fastener Manufacturing Research - Mechanical and Engineering Theories Manufacturing and Related Processes 3
J Research Use Only (RUO) Medical Devices and FDA Registrar Corp 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
V Depth of Internal Auditing and Training aspects in Research & Development (R & D) Internal Auditing 4
B How do you Research Job Openings? Career and Occupation Discussions 6
D Research, Design and Development Costing Model Procedure Business Continuity & Resiliency Planning (BCRP) 7

Similar threads

Top Bottom