SBS - The best value in QMS software

What should be included in the supply contract - Annex 2 list B IVD

nickie

Starting to get Involved
#1
We are a small company wishing to distribute an annex 2 list B IVD, manufactured by an ISO 13485 certified company in China. We are working towards ISO13485 certification. I'm looking for some help with what should be included in the supply contract from our point of view regarding things like PMS, vigilance, traceability, managing changes etc. Is specifying these requirements necessary or is it assumed within their CE approval and ISO13485 certification that they would notify us of any quality issues automatically? Presumably they will expect the contract to contain the requirement to notify them if we became aware of any problems with the product? Any help with what should be included and drafting the wording of a contract would be very gratefully received. Thank you.
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
Clarification of “distribute” is required.
Under whose name the device is going to be placed on the market (whose name and adress are on the label)?
Does the Chinese manufacturer also have an EC certificate for the device, or just ISO 13485 certification?
 
Last edited:

nickie

Starting to get Involved
#3
Thank you for your reply. The product is to be placed on the market in the manufacturer's name; we are merely the distributor. The Chinese company have CE certification for the product. I am aware that the new regulations place additional responsibilities on importers and distributors ( we are both in this case.) I am just unsure since they have all regulatory approval and quality systems in place whether we still need to spell out what we need from them, and if so how to word it.
 

Ronen E

Problem Solver
Staff member
Moderator
#4
We are a small company wishing to distribute an annex 2 list B IVD, manufactured by an ISO 13485 certified company in China. We are working towards ISO13485 certification. I'm looking for some help with what should be included in the supply contract from our point of view regarding things like PMS, vigilance, traceability, managing changes etc. Is specifying these requirements necessary or is it assumed within their CE approval and ISO13485 certification that they would notify us of any quality issues automatically? Presumably they will expect the contract to contain the requirement to notify them if we became aware of any problems with the product? Any help with what should be included and drafting the wording of a contract would be very gratefully received. Thank you.
Thank you for your reply. The product is to be placed on the market in the manufacturer's name; we are merely the distributor. The Chinese company have CE certification for the product. I am aware that the new regulations place additional responsibilities on importers and distributors ( we are both in this case.) I am just unsure since they have all regulatory approval and quality systems in place whether we still need to spell out what we need from them, and if so how to word it.
Thanks for clarifying.

You have asked “what should be included in the supply contract”.
“Should” as in...
- what the “old” (current) IVD directive requires?
- what the new IVDR requires (in effect, will require)?
- what ISO 13485 (2016?) requires?
- what would serve you best commercially / legally (contractual aspect)?
- what common sense would say?

I wouldn’t worry too much about what the Chinese manufacturer will ask to include in the contract; they will take care of their own interests and regulatory obligations. You just have to address the specifics as they come up during negotiations. Since you are merely distributors you don’t have a regulatory responsibility, at least not under the current regime, so you hardly need to cover any bases. Even under ISO 13485 you have quite a limited responsibility because in essence you are simply buying and selling a product unchanged. It probably boils down to receiving inspection to ensure your orders are fulfilled as issued.
 

nickie

Starting to get Involved
#5
What prompted my initial enquiry is that we have the opportunity to supply this IVD to a big customer. They require the companies they deal with to be ISO13485 certified, or if they are not the manufacturer to send them the quality agreement between us and the OEM. I need to put something in writing, however brief, and would really appreciate knowing what this should cover. Thanks.
 
Thread starter Similar threads Forum Replies Date
J Should Loading and Unloading be Included in Cycle Times? Lean in Manufacturing and Service Industries 14
S Should safety checks be included in the Control Plan? IATF 16949 - Automotive Quality Systems Standard 5
H Statistical Techniques Procedure - What should be included Document Control Systems, Procedures, Forms and Templates 4
D Should "Waste" be included as Output in SIPOC Chart? Process Maps, Process Mapping and Turtle Diagrams 8
S Should Training Service providers be included in AVL? ISO 13485:2016 - Medical Device Quality Management Systems 7
D What should be included in Management Review Meeting for ISO 9001:2015? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
L Departmental Management Meetings -Topics which should be included IATF 16949 - Automotive Quality Systems Standard 4
W AS9102 Requirements - What information from the PO should be included in the FAIR? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
R QMS System Upgrading - Should the HSE and Finance functions be included? Quality Manager and Management Related Issues 15
K PPAP Cost - Cost of PPAP should be included in the quote? APQP and PPAP 5
H What should be included in a Machining Process FMEA? FMEA and Control Plans 8
T TS16949 Certification withdrawn - What should be included in a formal appeal request? IATF 16949 - Automotive Quality Systems Standard 3
J What should be included in the Design Change Document 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
K Should prices be included in customer related process ISO 13485:2016 - Medical Device Quality Management Systems 1
R Which information about predicate device should be included in 510k submission? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
C MR Service Contract - What should be included ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
J Quality Policy - should a brief description of the company & its product be included? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
S What should be included in training documentation Training - Internal, External, Online and Distance Learning 19
B What other activities should be included in a Continuous Improvement process? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
D Should QSRD codes be included in Documents Submitted to Regulatory Bodies? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 0
D Should Sales & Marketing be included in Product Realization? IATF 16949 - Automotive Quality Systems Standard 12
H Nonconforming Material Tag? Description or template of what items should be included ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
N Containment Plan - When is a containment plan required and what should be included? APQP and PPAP 1
A Should we assign the PRRC before the date of application of MDR (26 May 2021)? EU Medical Device Regulations 0
J UDI-DI how should we interpret Device version or model to determine if a new UDI-DI is needed? EU Medical Device Regulations 0
Sidney Vianna Interesting Discussion Should ISO 9004 be changed from a guidance document to a requirements standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
A Should I take an online course for a career in Occupational Health and Safety? Career and Occupation Discussions 2
J Should a Class 1 medical device with an option to measure body weight be considered Class 1m? EU Medical Device Regulations 0
K Should APQP/PPAP has its own section in a QM? Quality Management System (QMS) Manuals 1
S What should i choose for "testing procedure" characteristics? (N95) General Information Resources 0
P Should eIFU link per ISO 15223-1:2016 be added to labels out of scope of Reg 207/2012? EU Medical Device Regulations 1
S Which Sampling Plan(s) Should I Use? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 7
A Document release vs its related training. Which should come first? ISO 13485:2016 - Medical Device Quality Management Systems 18
S Which department should prepare the control plan? could you show me a standard regarding to this matter. FMEA and Control Plans 17
J Help settle a disagreement: Should external providers of preventive maintenance be on your ASL? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
N Master Samples - What should we be keeping? IATF 16949 - Automotive Quality Systems Standard 9
G Supplier delivered recent PPAP, should he deliver yearly layout inspection? IATF 16949 - Automotive Quality Systems Standard 4
John Broomfield Vote - Should ISO9004 Become a Requirements Standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
A Capability Study - in the beginning of your career what should you have known about the tool Quality Tools, Improvement and Analysis 11
E Manufacturers should develop a testing device for covid19 Service Industry Specific Topics 0
T 510(k) submission - Which name should I use in the submission? Other US Medical Device Regulations 3
N ISO 19011:2018 - 5.4.2 "...audit program should engage in appropriate continual development..." Training - Internal, External, Online and Distance Learning 4
G Should I perform Gage R&R only at the beginning of a new project? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6
DuncanGibbons Should the requirements FAA/EASA Part 21 be addressed within the QMS and AS9100D quality manual? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
M Should 510(k) Predicates be Actively Listed Devices? Other US Medical Device Regulations 12
B Why the Greek god Hephaestus should have done a design FMEA (DFMEA) on his giant robot APQP and PPAP 1
J On PFMEA for danger labels - Label always should be assigned severity 10 ? FMEA and Control Plans 3
H Who should be listed as the manufacturer/distributor on the box? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 15
M MDR, RED and LVD - Should our device comply with them? EU Medical Device Regulations 3
BeaBea How Many Processes should be created for each Department? Process Maps, Process Mapping and Turtle Diagrams 5

Similar threads

Top Bottom