UDI implementation with contract manufacturer

N

NicoleinFlorida

#1
Hello everyone,

I have a question about the UDI implementation.

We are using GS1 for the compliance of UDI. However, the contract manufacturer of our company is a foreign establishment. And most of the employees are not competent with English. Therefore, it will be very difficult for our supplier to control the bar-codes by using a system in English.

Does any of you have similar situation? And please provide some recommendations.

Thank you in advance.

Yiling
 
Last edited by a moderator:
Elsmar Forum Sponsor
M

missjenny

#2
I am situated in Korea at the moment and GS1 Korea had some of their guidance documents translated into Korean. Perhaps, you could check whether GS1 has a local branch and ask them to help you.
 
N

NicoleinFlorida

#3
Thank you so much, Missjenny.

I have checked the GS1 website, it has local branch there. You are so helpful!!!!
 
Thread starter Similar threads Forum Replies Date
L UDI implementation in Saudi Arabi (KSA) Other Medical Device Regulations World-Wide 1
J Looking for a template SOP for UDI implementation for EU Medical Devices EU Medical Device Regulations 2
M UDI transition period and implementation EU Medical Device Regulations 6
K China UDI Implementation for October 1st 2019 China Medical Device Regulations 4
F What is the European UDI implementation timeline? EU Medical Device Regulations 3
D UDI-DI and UDI-PI labelling EU Medical Device Regulations 1
I Higher level of packaging UDI-PI EU Medical Device Regulations 8
R UDI dates EUDAMED EU Medical Device Regulations 0
I UDI in Europe and US EU Medical Device Regulations 3
G UDI in EU vs FDA EU Medical Device Regulations 1
G UDI or not? EU Medical Device Regulations 0
M UDI IVD - before submission? US Food and Drug Administration (FDA) 2
N UDI for OTS Components Other US Medical Device Regulations 1
J Assigning UDI's for own brand products EU Medical Device Regulations 11
M UDI IVD Medical Device Class III US Food and Drug Administration (FDA) 1
E UDI on product/packaging levels EU Medical Device Regulations 8
O 14-digits UDI EU Medical Device Regulations 3
L Looking for SOP Template for UDI under MDR EU Medical Device Regulations 4
P MDR Article 27 - UDI - Keeping records of UDIs EU Medical Device Regulations 1
S BASIC UDI-DI for a class IIa device marketed in a Procedure kit EU Medical Device Regulations 1
C UDI assignment and labeling. EU Medical Device Regulations 4
C Labelling and UDI Requirements - Implications of serial numbers US Medical Device Regulations 1
D Basic udi-di to not appear on IFU? EU Medical Device Regulations 4
R Legacy Device UDI Requirements EU Medical Device Regulations 9
R UDI Requirement at home patient use EU Medical Device Regulations 2
P UDI on devices exclusively intended for retail point of sale EU Medical Device Regulations 3
J UDI and Labelling hierarchy and requirements for separate device components EU Medical Device Regulations 7
M UDI barcode quality EU Medical Device Regulations 3
C How to place software version for SaMD product in HIBC secondary data structure (UDI-PI)? Other US Medical Device Regulations 4
C Issues with UDI-DI and LAA/LUA registration in Eudamed EU Medical Device Regulations 2
Watchcat Mobile app - Different UDI for different smartphones? Other US Medical Device Regulations 7
Watchcat One UDI per country? ISO 13485:2016 - Medical Device Quality Management Systems 3
Watchcat UDI Timeframes? Other US Medical Device Regulations 7
A UDI-PI for IVDs used in house EU Medical Device Regulations 5
G SRN, Basic UDI, Legal Manufacturer EU Medical Device Regulations 6
A Basic UDI and UDI-DI for hip implant systems EU Medical Device Regulations 1
T FDA UDI Question - Class II Medical Device Other US Medical Device Regulations 2
R UDI Number Identification EU Medical Device Regulations 5
I Eudamed UDI-Module EU Medical Device Regulations 9
L Configurable UDI mdr EU Medical Device Regulations 0
L UDI-DI - Device will be sold by itself in a box EU Medical Device Regulations 2
P Basic UDI-DI and Legacy Devices EU Medical Device Regulations 19
C UDI for consumable/replacement components under the MDR EU Medical Device Regulations 7
K UDI for two units with different S/N on the same package/case Other US Medical Device Regulations 10
C Validation of process for releasing the UDI EU Medical Device Regulations 4
A MDR requirement where unit of use packaging is too small for UDI carrier EU Medical Device Regulations 1
L UDI needed when we submit to ON? EU Medical Device Regulations 5
S Does a refurbished product required a new UDI? US Food and Drug Administration (FDA) 3
A UDI for product already packed up EU Medical Device Regulations 0
M Brand owner or manufacturer responsible for Basic UDI-DI and UDI-DI? EU Medical Device Regulations 8

Similar threads

Top Bottom