Reseller Request to Change UPC on Medical Device via Re-labeling

S

SGquality

Quite Involved in Discussions
My question relates to a Class I medical device in US. My company is in talks with a big reseller for selling a Class I medical device but they have told us that we should be changing our UPC and should be affixed as a sticker. Currently our device has a UPC and UI identified on the device.

Can I know if anyone has been in this situation and also, if its an acceptable proposal?

Thank you!
 
C

Cybel

Involved In Discussions
We sell products with the customer's UPC (and UDI) when they are sold under the customer's own brand: in this case the customer figures out as labeler, and it is registered in the GUDID accordingly.

Has the reseller asked you to just put a different UPC on your standard product or is the product somewhat customized?
 
C

Cybel

Involved In Discussions
I cannot guess any reason for it. However, as the GTIN of UPC shall correspond to the GTIN of UDI-DI, I suppose that if they want your product has their own UPC, you shall also change the UDI and they have to register it in the GUDID.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
Q ISO 9001 - Reseller Exclusions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
BeaBea Registrars with VAR (Value Added Reseller) experience Registrars and Notified Bodies 8
K IATF 16949 Reseller Requirements IATF 16949 - Automotive Quality Systems Standard 3
M Virtual Manufacturer vs Reseller (Medical Devices) EU Medical Device Regulations 0
qualprod Non applicable clauses in a reseller? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
K Classification of the Reseller of Stand Alone Medical Device Software ISO 13485:2016 - Medical Device Quality Management Systems 3
Y Quality Manual sample for a RESELLER of networking equipment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
M CE requirement for software importer / reseller - Class II for FDA and Health Canada EU Medical Device Regulations 1
M Buyout/partnership/reseller offer from ISO 9000 USA legit? Coffee Break and Water Cooler Discussions 9
Feninaar Request for Power of Attorney Template Buy, Sell or Trade - NO Commercial Advertisements 1
A What specific Quality "Must have's" would you like included in a Request For Quotation? Customer and Company Specific Requirements 3
S F-108 Request for Expansion of Scope of Accreditation ISO 17025 related Discussions 2
I Request for information regarding remote medical monitoring software (its technical documentation and the IUD system) IEC 62304 - Medical Device Software Life Cycle Processes 2
H Ever given an Operations Manager an internal Corrective Action Request? Nonconformance and Corrective Action 5
G Notified body quotation request ISO 13485:2016 - Medical Device Quality Management Systems 2
Ed Panek Consultant Request SaMD AI "Expert" FDA US Food and Drug Administration (FDA) 2
somashekar Stage 1 Finding. Request views and comments ISO 13485:2016 - Medical Device Quality Management Systems 3
E DESIGN VALIDATION, USABILITY AND CLINICAL EVALUATION request Medical Device and FDA Regulations and Standards News 0
M Resume Review Request - Quality Assurance Career and Occupation Discussions 11
N API Q1, Management of Change & Document Change Request Oil and Gas Industry Standards and Regulations 4
Watchcat Change Request Documents - What's Typical These Days? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 14
Q Request Calibration Info Calibration and Metrology Software and Hardware 16
J Drawing Example Request: Inspection Section Plane of Aluminum Casting Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
M Pre-Sub preparation (for de Novo request) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
J Supplier not responding to PPAP request APQP and PPAP 5
E Document Change Request forms (or no forms)? ISO 13485:2016 - Medical Device Quality Management Systems 9
L Clinical research - Request from ANVISA ISO 14971 - Medical Device Risk Management 1
B IATF16949 audit requirement - Auditor request UCL and LCL must be show Xbar-R, IATF 16949 - Automotive Quality Systems Standard 7
E Annual PPAP+ deviation request ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
G IMS (Integrated Management System) 9001, 14001 & 45001- Request Assistance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
F ISO 13485 - EU countries that could request another audit ISO 13485:2016 - Medical Device Quality Management Systems 2
M Customers Request AS9100 certification - Small Company (less than 20 employees) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
C New to Site - Request Help with API Q2 Implementation Oil and Gas Industry Standards and Regulations 9
O ISO 9001 new certification advice request - Develop a QMS from scratch ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
M Informational Draft standardisation request as regards medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Medical Device and FDA Regulations and Standards News 2
T NAFTA request for form with no part numbers showing Supply Chain Security Management Systems 0
R IATF Exemption Request Letter IATF 16949 - Automotive Quality Systems Standard 0
M 8.3.2.3 Development of products with embedded software - request for clarification IATF 16949 - Automotive Quality Systems Standard 1
W Part Change Request - Standard (OTS) electronic parts (resistors, capacitors etc.) IATF 16949 - Automotive Quality Systems Standard 3
C Supplier blowing off CAR request Registrars and Notified Bodies 14
S PPT for ISO13485:2016 Employee Training (Request) ISO 13485:2016 - Medical Device Quality Management Systems 0
D IMDS for machining - Can my customer request a IMDS number for a part? APQP and PPAP 2
E CAR (Corrective Action Request) Due Dates ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
J Class 1 Medical Device ECR (Engineering Change Request) Changes 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
M Is it ok to provide a different language upon request? EU Medical Device Regulations 25
B Supplier is denying visit request Supplier Quality Assurance and other Supplier Issues 52
B Request for Information; Application for Accreditation Japan Medical Device Regulations 0
S Engineering change order versus a design change request ISO 13485:2016 - Medical Device Quality Management Systems 1
L Quality Manual for a Quality Plan (Manufacturing secrets?) Request Misc. Quality Assurance and Business Systems Related Topics 1
S What is the difference between a service request and a complaint? ISO 13485:2016 - Medical Device Quality Management Systems 2

Similar threads

Top Bottom