Design Control for Relabeling and Repackaging

A

Alexlefei

#1
I want to know what design control we need to have if we just relabel an outsourced product into our own brand.

We are an IVD manufacturer and we are planning to add a few new products into our catalog. We have found some potential vendors. What we do is we purchase these tests from the vendors and relabel them into our own brand.

I know that we are considered to be manufacturer. But I am not sure what design control we should have in place to fulfill different regulation requirements.
 
Last edited by a moderator:
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
Hello and welcome to the Cove :bigwave:

Are those tests already cleared for US distribution, before you relabel them?

Someone has to be responsible for the design of those devices. If they are already cleared, you are only responsible for the new labeling (if that includes a modified intended use, I would say that it includes some design responsibility). If you are the first to clear them under US regulation, it doesn't matter that practically you are only relabeling. In my opinion in the latter scenario you'd also be responsible for the design. Regulatory responsibility for the design entails a requirement for some level of design control.

This is my general view, without knowing the actual classification and other specifics.

Cheers,
Ronen.
 

sreenu927

Quite Involved in Discussions
#3
Hi..It all depends on the market you would like to enter. It seems, for US, this strategy is called as "Private Labeling" or "Private branded products", where by the design, manufacture and regulatory pathway is owned by your vendor. You will be the importer and distributor of the product under your own brand.
It will be entirely a different scenario if it is EU and APAC. There is no such concept of private label in these regions.
You have to be a legal manufacturer or a distributor with co-branding strategy.

Regards,
Sreenu
 
A

Alexlefei

#4
Hi..It all depends on the market you would like to enter. It seems, for US, this strategy is called as "Private Labeling" or "Private branded products", where by the design, manufacture and regulatory pathway is owned by your vendor. You will be the importer and distributor of the product under your own brand.
It will be entirely a different scenario if it is EU and APAC. There is no such concept of private label in these regions.
You have to be a legal manufacturer or a distributor with co-branding strategy.

Regards,
Sreenu
I think I have got the answer. As long as you label it into your own company's brand name, you are responsible for design control of the product, at least to some extent.
 
A

Alexlefei

#5
Hello and welcome to the Cove :bigwave:

Are those tests already cleared for US distribution, before you relabel them?

Someone has to be responsible for the design of those devices. If they are already cleared, you are only responsible for the new labeling (if that includes a modified intended use, I would say that it includes some design responsibility). If you are the first to clear them under US regulation, it doesn't matter that practically you are only relabeling. In my opinion in the latter scenario you'd also be responsible for the design. Regulatory responsibility for the design entails a requirement for some level of design control.

This is my general view, without knowing the actual classification and other specifics.

Cheers,
Ronen.
Yes, the tests are cleared for distribution under the vendor's brand name.
 

QA-Man

Involved In Discussions
#6
I want to know what design control we need to have if we just relabel an outsourced product into our own brand.

We are an IVD manufacturer and we are planning to add a few new products into our catalog. We have found some potential vendors. What we do is we purchase these tests from the vendors and relabel them into our own brand.

I know that we are considered to be manufacturer. But I am not sure what design control we should have in place to fulfill different regulation requirements.
You would be developing labeling specifications, packaging specifications (your shipping box), manufacturing work instructions (relabeling instructions), etc. You might even do some risk management and discover you want the IFU to give a little more info. Even though you're not designing the "core" product there are still some design activities going on.
 

Ronen E

Problem Solver
Staff member
Moderator
#7
You would be developing labeling specifications, packaging specifications (your shipping box), manufacturing work instructions (relabeling instructions), etc. You might even do some risk management and discover you want the IFU to give a little more info. Even though you're not designing the "core" product there are still some design activities going on.
I wouldn't necessarily assume all that. To me it sounds more like a straightforward private label case, where the only differences are brand name, address and the like, and there is no physical relabeling because the OEM manufactures the devices (including packaging and labeling) with the private label upfront. I'm not even sure that "relabeling" is the accurate classification of that set-up.

Hopefully the OP will clarify.

If your assumptions are correct (ie there are changes in packaging, IFU etc.) then I agree that there is some design going on and therefore design control is required.
 
Thread starter Similar threads Forum Replies Date
W Need for current design or process control FMEA and Control Plans 2
A What is the difference between Design Process, Process Design and Design Control? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
T Design Control Procedures later in the Development Process ISO 13485:2016 - Medical Device Quality Management Systems 6
Q Relabeler for patent expired product - design control responsibilities? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
A UDI and Design Controls - Labeling change via the Design Control process 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
C Design Control - Ways of capturing inputs from manufacturing Other Medical Device Related Standards 5
M Medical Device Design Control Auditor Recommentations General Auditing Discussions 19
R Operator's manuals as prevention design control FMEA and Control Plans 2
S Design Control for Class I Medical Devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
C Defining Approvals Required for Design Control Documents ISO 13485:2016 - Medical Device Quality Management Systems 6
C Design Transfer - How do you guys control the design transfer process? Document Control Systems, Procedures, Forms and Templates 5
S Is Human Factor Testing required as part of Design Control Validation? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
W Design Control Assistance required ISO 14971 - Medical Device Risk Management 7
V For a Drug-Device Combination Product, 'Design Control' Process is triggered at? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
J Design Control - Can Validation be based on a limited/first Production Run ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
N Dual ISO 9001 (Manufacturing) and ISO 13485 (Design Control) for same product line ISO 13485:2016 - Medical Device Quality Management Systems 3
J Incoming Inspection Plans under Design Control (part of DMR)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
V Design & Documentation of Control Systems and Procedures Document Control Systems, Procedures, Forms and Templates 11
C How to evaluate the Detection Ranking of a new Design Control FMEA and Control Plans 1
A Design Control Requirements: IDE exempt, NSR Device (Clinical Study) US Food and Drug Administration (FDA) 2
M Class II Medical Device Design Control Non Conformance 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
I Content to be included or excluded in Design Control Meeting Minutes ISO 13485:2016 - Medical Device Quality Management Systems 4
H ISO 9001 Document Control Requirements - Design and Development Department Checklists Document Control Systems, Procedures, Forms and Templates 3
M QSR - Design Control on Existing Device not Designed following QSR 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
H Medical Device Design Control Requirements (820.30) on Existing Products 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
S Internal Design Control Audit ISO 13485:2016 - Medical Device Quality Management Systems 5
E Better control of DHR (Design History Record) during processing Document Control Systems, Procedures, Forms and Templates 5
D Class I and Class II Medical Device Accessory Design Control Requirements US Food and Drug Administration (FDA) 3
G Understanding Identification of Design in QSR 21 CRF Part 820.30 Design Control (f) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Q Tracking Log for IP during Design Control Process Document Control Systems, Procedures, Forms and Templates 1
K 7.3.7 Control of Design & Development Changes AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
K Design Control - Parent Company is located in Australia 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
S New Requirements for Design Control in AS9100 C AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
W Design History Verification Records Control and Approvals US Food and Drug Administration (FDA) 3
B Design Control and Release Manual plus a Quality Manual Quality Manager and Management Related Issues 13
K Design Control SOP - Streamlining with R&D Department ISO 13485:2016 - Medical Device Quality Management Systems 6
A R&D Design Control - Ideas to Improve the Quality of Drawings Design and Development of Products and Processes 7
H Design Control Requirement - Initial Distributor of a Class I Video Laryngoscope US Food and Drug Administration (FDA) 4
M ISO 17025 and Design/Process Control Requirements ISO 17025 related Discussions 2
bobdoering Myth or Mythunderstanding: Implications of the Economic Design of Control Charts Statistical Analysis Tools, Techniques and SPC 1
C At what stage does Design Control play a role in Medical Device Development ISO 13485:2016 - Medical Device Quality Management Systems 2
B Suggestions on how to control a Design Dossier? Document Control Systems, Procedures, Forms and Templates 2
T Request for a Design Control Procedure or Process Flow for HVAC Design Document Control Systems, Procedures, Forms and Templates 1
A Design/Change Control Procedure - How to cope with Changes during Development? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 26
J What things go in Design Control Documentation for a 510k of Class II Medical Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
J Design Control & Rapid Prototyping - Medical Device Software 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
S Declaration of Conformity to Design Control 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
S Declaration of Conformity to Design Control 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
A QSR (820.30 part e) Design Review and Design Control Responsibilities 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
M Procedure for Control and Maintain of Records in each Design Stage 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8

Similar threads

Top Bottom