Introduction of Compulsory Bar Coding of Medical Devices in the US?

L

Laurie Anderson

#1
Hi there.

Just one short question!
Does anyone out there have any knowledge in regard to the introduction of compulsory Bar Coding of Medical Devices? I believe there is already legislation in the US awaiting introduction and as I am lead to believe the EEC is not far off either. I have read a some articles to indicate this, but there may be something out there with more substantial information that I am missing

Just curious if anyone else has heard, read anything on the subject?

Laurie
 
Elsmar Forum Sponsor
L

Laurie Anderson

#4
Thanks Qualityalways and Harry

It would appear none of us are any the wiser on the subject.

I guess its a waiting game although we are going ahead with it for one small market in Europe (not an EU Member), but they are insisting on the grounds that it will become mandatory in the EU by 2010.

We have made inquiries with the authorities and our registrar, yet no one has any information that would throw any light on the subject.

Thanks again guys,

Laurie
 
F

freelovefest

#5
You might find this useful. It is a presentation from clinivation. It is free on their website so there should be no issue with posting it here. It speaks about unique device identifiers and how they may eventually be required. Barcoding is certainly one way of doing this. I doubt this is coming any time too terribly soon though. It would be a pretty tough thing to implement across the industry.
 

Attachments

T

Thomas Dwyer

#6
Re: Introduction of Compulsory Bar Coding of Medical Devices in Turkey

Has anyone hear about manditory requirements for unique device identification for Turkey? Such as GTIN per GS1?

I have been told we need the barcode in order to submit a tender.

Can one obtain the code from other companys, $20 K is a bit steep.
 
S

spursqa - 2009

#7
Yes - I have also come across this problem for Turkey.
Does anyone have any information on how to get over this, and what other countries will be adopting the same compulsory Bar Coding?

Thanks
 
T

Thomas Dwyer

#8
We joined GS-1, and now have a GTIN-13 number. I understand FDA is leaning this way for medical devices in USA, Japan is also developing similar requirements.
 
C

Conquer

#9
Turkey requires the bar code for reinbursement purposes. My understanding is that if you want to get paid for use of the medical device you need to have a bar code in their database system.
 
E

E. Madsen - 2012

#10
We are looking at barcoding our medical devices. :) Does anyone know how we should apply for barcodes for our products? Do we just need to get a UPC code or do we need to apply for a barcode with the FDA?

We sell in Europe, US, and Canada. I haven't looked into barcoding for Europe and Canada yet, so that information will also help me!

Thank-you!!
E. Madsen
 
Thread starter Similar threads Forum Replies Date
G Question about Non-conformances during New Product Introduction Nonconformance and Corrective Action 14
S MDR & IVDR Introduction in late May 2017 EU Medical Device Regulations 1
S New Product Introduction Procedure - NPI Document Control Systems, Procedures, Forms and Templates 1
V Design Transfer to production = New product introduction ?? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
E Does introduction of a new brochure require a 510K? US Food and Drug Administration (FDA) 7
K Auditing New Product Introduction Process General Auditing Discussions 21
K NPI (New Product Introduction) Quality Plan Outsourced Manufacturer/Supplier APQP and PPAP 3
A What should be the contents of the New Gage Introduction Form ? General Measurement Device and Calibration Topics 3
T Raw Parts Inspections for NPI (New Product Introduction) Phase Supplier Quality Assurance and other Supplier Issues 1
A Food Warehouse ISO 9001 Audit and Newbie Introduction ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A Changes required to procedures after introduction of SAP Document Control Systems, Procedures, Forms and Templates 3
J EC Certificate and European Market Introduction CE Marking (Conformité Européene) / CB Scheme 8
AnaMariaVR2 Pharma ?Quality by Design? (QbD): An Introduction, Process Development & Applications Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
M Introduction to the Medical IT, Medical software and Health Informatics forum Medical Information Technology, Medical Software and Health Informatics 4
P Introduction of SPC to the Supply Chain Statistical Analysis Tools, Techniques and SPC 18
M NPDI (New Product Development & Introduction) Examples needed Excel .xls Spreadsheet Templates and Tools 3
S Monozukuri Rules for NPI (New product Introduction) - Help to get Lean in Manufacturing and Service Industries 3
D Introduction Coffee Break and Water Cooler Discussions 4
V Introduction Imported Legacy Blogs 6
E FDA New Product Introduction Regulations help needed 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M TPM Announcement Letter for TPM introduction in a organisation Lean in Manufacturing and Service Industries 3
U Introduction of SPC - Embarking on my first implementation for precision machining Statistical Analysis Tools, Techniques and SPC 11
A QMS Introduction - I have been asked to give a brief introduction of our QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
B New Product Development and Introduction Manual Manufacturing and Related Processes 5
P Introduction & Latest version of AIAG Control Plan request IATF 16949 - Automotive Quality Systems Standard 3
Hershal Introduction to ANS/ISO/IEC 17025 and Z540 ISO 17025 related Discussions 2
Q Procedure for New Product Introduction (NPI) - Build to print shop Various Other Specifications, Standards, and related Requirements 6
S NPI (New Product Introduction) in Electronics Industries Document Control Systems, Procedures, Forms and Templates 10
A Introduction of EN 62304 - Life Cycle Requirements for Medical Device Software. IEC 62304 - Medical Device Software Life Cycle Processes 43
Y NPI (New Product Introduction) Process Qualification System Required Document Control Systems, Procedures, Forms and Templates 8
G Introduction to TS 16949 - Excel Partnership Course Training - Internal, External, Online and Distance Learning 4
Manix TS16949 Training Requirements - Basic introduction to the standard vs. Lead Auditor Training - Internal, External, Online and Distance Learning 8
J Free Introduction Course - VBA (Visual Basic for Application) in Excel to make forms Excel .xls Spreadsheet Templates and Tools 10
C Definition NPI (New Product Introduction) Readiness - Definition Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 9
B Educating Employees - Introduction to what quality is all about ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
M Six Sigma .ppt or .doc Presentations - Awareness session or introduction wanted Training - Internal, External, Online and Distance Learning 17
A Design document - Seeking "New Product Introduction" manual example Design and Development of Products and Processes 7
K Games for training - Introduction to ISO 9001 for Upper Management Quality Manager and Management Related Issues 9
R Where can I get ISO 13485:2003 Introduction Training Videos Training - Internal, External, Online and Distance Learning 3
G Introduction of ISO/IEC17024:2003 in Australia General Auditing Discussions 3
D ISO 9001 Introduction and Training for Employees Training - Internal, External, Online and Distance Learning 36
D Fresh Coffee - An Introduction Coffee Break and Water Cooler Discussions 65
G When Do I Start FMEA? During project introduction? FMEA and Control Plans 5
M Is it compulsory to update the obsolete GMDN codes in ARTG? Other Medical Device Regulations World-Wide 4
G Is it compulsory to make DFMEA for proto parts making organisation APQP and PPAP 1
H Is Product Liability Insurance Compulsory for Medical Device Manufacturers? Other Medical Device Regulations World-Wide 2
K ISO 14001 Clause 4.3.3 - Compulsory Objectives ISO 14001:2015 Specific Discussions 1
R UL & CCC (China Compulsory Certification Mark) Certification Requirements Various Other Specifications, Standards, and related Requirements 1
P Is it compulsory to send new measuring equipment for calibration / verification? Calibration Frequency (Interval) 3
K Calibration Stickers on Measurement Equipment - Compulsory or not General Measurement Device and Calibration Topics 23

Similar threads

Top Bottom