Distributors and ISO 13485 - DHF and DMR Responsibilities

O

orangeisenergy

#1
If my company is going to distribute a device that we are having co-manufactured (our name on the product), and we are ISO 13485 certified, but the company manufacturing our product is not, what requirements as far as ISO 13485 is concerned are there? Can the manufacturer hold the DHF and DMR, or do we need them since our name will be on the label? Can we just distribute and maintain our portion of the traceability and call it good?

:popcorn:
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
Hi,

If my company is going to distribute a device that we are having co-manufactured (our name on the product), and we are ISO 13485 certified, but the company manufacturing our product is not, what requirements as far as ISO 13485 is concerned are there?
Being the legal manufacturer (your name on the product), you are responsible. As far as ISO 13485 is concerned there are no requirements other than you following your own SOPs regarding selection, approval and control of your suppliers (the co-manufacturing company is your supplier). Of course, your purchasing controls should be aligned with ISO 13485.

Can the manufacturer hold the DHF and DMR, or do we need them since our name will be on the label?
DHF and DMR are part 820 (FDA) terms, not ISO 13485, though ISO 13485 has similar concepts. Again, you have the ultimate responsibility, so if you don't physically hold and control the files, you'll at least have to have strong provisions in place to ensure real time accessibility and being fully and continuously up to date with any content change.

Can we just distribute and maintain our portion of the traceability and call it good??
As long as your supplier (co-manufacturing company) covers the areas which you don't, so that ISO 13485 is fully complied with, and you have provisions in place to ensure that this will be the situation at all times, it's OK. The ultimate responsibility is yours. How you go about making sure you keep up with it has some degrees of freedom. The key word is Control.

Cheers,
Ronen.
 
Last edited:

somashekar

Staff member
Super Moderator
#3
If my company is going to distribute a device that we are having co-manufactured (our name on the product), and we are ISO 13485 certified, but the company manufacturing our product is not, what requirements as far as ISO 13485 is concerned are there? Can the manufacturer hold the DHF and DMR, or do we need them since our name will be on the label? Can we just distribute and maintain our portion of the traceability and call it good?

:popcorn:
All the requirements of the ISO 13485 are there for you.
What is your scope of ISO 13485 QMS as on your certificate ? (Gives a good insight)
I am a little surprised that the company manufacturing for you is not ISO 13485.
There seems to be a lot of "Outsourcing" in your QMS, and it is good to know how the controls are placed and how they are operating and being effective in your QMS.
I hope you can give more details to say how the processes are stitched together between you and the manufacturer.
 
O

orangeisenergy

#4
All the requirements of the ISO 13485 are there for you.
What is your scope of ISO 13485 QMS as on your certificate ? (Gives a good insight)
I am a little surprised that the company manufacturing for you is not ISO 13485.
There seems to be a lot of "Outsourcing" in your QMS, and it is good to know how the controls are placed and how they are operating and being effective in your QMS.
I hope you can give more details to say how the processes are stitched together between you and the manufacturer.
Our scope is ?the design, development and manufacture of in-vitro microbiological diagnostic testing media.?
Does this include veterinary devices, or is this just for devices for humans?
Does a PCR type in vitro diagnostic test for animals fall in this scope?

This is the only outsourcing we do. And this is a new venture for everyone here. The company that is going to manufacture the new product for us has never manufactured before. They have been strictly R & D by contract previously. They do not hold a ISO13485 certification.
 

somashekar

Staff member
Super Moderator
#5
Does this include veterinary devices, or is this just for devices for humans?
If your scope is what you said in your ISO 13485 certificate, then it implies that the testing media is used for human beings. It matters little if it can also be used for veterinary application.
Does a PCR type in vitro diagnostic test for animals fall in this scope?
No, if it is exclusively for animals. Your quality manual can mention this with a simple reasoning. (I am sure you treat this no differently in QMS though)
Your scope implies that the DHF and DMR are your records. They must be under your records control. It matters little who actually made those records. You own it.
The company that is going to manufacture the new product for us has never manufactured before. They have been strictly R & D by contract previously. They do not hold a ISO13485 certification.
This may be against your evaluation and selection of the company to manufacture. However if this is your organization requirement, define your criteria for contracting with that company. Establish new manufacturing contracts keeping in view your volumes, the infrastructure and work environment requirements and validation responsibilities clearly outlined. Drive them towards ISO 13485 certification with a time line project (preferably with your CB)
You can search here in the cove for a copy of good manufacturing quality agreement.
 
Last edited:

Ronen E

Problem Solver
Staff member
Moderator
#6
Our scope is ?the design, development and manufacture of in-vitro microbiological diagnostic testing media.?
Does this include veterinary devices, or is this just for devices for humans?
The scope includes whatever you clarify it does. You should be communicating it clearly to all stakeholders; in the case of ISO 13485 it is essential you communicate it clearly to your CB, so that they can audit you accordingly and state the right scope on your certificate. If you are enhancing your product line it should be discussed with the stakeholders, including your CB, and acted upon as necessary in real time (i.e. perhaps earlier than the annual surveillance audit). Apparently the scope you quoted above is not sufficiently clear in your current situation. IMO in the current context it is in your interest to further clarify that your ISO 13485 scope excludes products intended for animal use only. This would avoid ambiguity.

Cheers,
Ronen.
 

Ronen E

Problem Solver
Staff member
Moderator
#7
Drive them towards ISO 13485 certification with a time line project
IMO this is not a must. Before making any decision in that regard, the real needs and consequences are better considered. What real need drives the requirement for them to have ISO 13485 certification? Perhaps ISO 9001 would suffice instead?
 

somashekar

Staff member
Super Moderator
#8
IMO this is not a must. Before making any decision in that regard, the real needs and consequences are better considered. What real need drives the requirement for them to have ISO 13485 certification? Perhaps ISO 9001 would suffice instead?
Agree ... :yes:
Why I recommend to orangeisenergy is for the following reason.
1. The question is with ISO 13485 standard as the basis
2. They are on the product label and are ISO 13485 company
3. Significant processes are outsourced, and the QMS status of that company is not clear. It is however clear that they are new to manufacturing
4. Evaluation and selection criteria of the manufacturer is perhaps the ongoing association in design and development. No evidence of any other criteria
5. Information about quality management system requirements in purchasing is not evident to me

If the regulatory requirement is the US FDA, then ISO 13485 or ISO 9001 is not a requirement for either of the companies. Yes, perhaps ISO 9001 would suffice, but just an other few steps will take them to ISO 13485.
ISO 13485 certification mostly is from the business risk based decision.
 
Thread starter Similar threads Forum Replies Date
I Distributors for class II medical devices in US - Do we need ISO 9001 or ISO 13485 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
I ISO 9001 and VWAD (Verified-Accredited Wholesale Distributors certification) Coffee Break and Water Cooler Discussions 1
S ISO 9001 Standards for Stocking Distributors ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
T Different Authorized Representative and distributors in Saudi Arabia Other Medical Device Regulations World-Wide 0
T PPAP for distributors? APQP and PPAP 1
C ASL - Buying from unqualified manufacturers through qualified distributors Supplier Quality Assurance and other Supplier Issues 2
S Degree of control of distributors - PMS EU Medical Device Regulations 2
R Qualification of Distributors such as McMaster-Carr and Digikey to Medical Device Companies ISO 13485:2016 - Medical Device Quality Management Systems 3
JoCam Distributors Responsibilities - Medical Device Recalls EU Medical Device Regulations 1
H Supplier Development - Distributors only? The new GM Standards IATF 16949 - Automotive Quality Systems Standard 4
T Oversight of Distributors - Supply chain requirements under the MDR EU Medical Device Regulations 9
Sidney Vianna Informational UTC ASQR Rev.11 has a mistake; certification of distributors to IATF 16949 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
C Do Distributors need to register with competent authorities in the EU? EU Medical Device Regulations 2
JoCam Medical Device Certificates of Free Sale - Distributors EU Medical Device Regulations 9
J Recall Effectiveness - Accessory to Medical Devices shipped through Distributors Customer Complaints 3
D Customer Specific Requirements / Distributors (IATF 16949) Customer and Company Specific Requirements 1
H Local Representative / Distributors - United Arab Emirates Other Medical Device Regulations World-Wide 2
Sidney Vianna IAF Endorsed Accredited 13485 Certification helping Control of Medical Distributors ISO 13485:2016 - Medical Device Quality Management Systems 0
M What level of control should be exercised on distributors? Supplier Quality Assurance and other Supplier Issues 10
C Multiple distributors in Spain EU Medical Device Regulations 2
F Distributors Audit guide Supplier Quality Assurance and other Supplier Issues 4
B Own Brand Labelling and Distributors - Self Test IVD's EU Medical Device Regulations 3
Y Is CFDA registration required if the full system is registered by our distributors? China Medical Device Regulations 2
JoCam Choose Medical Device Distributors prior to Device Registration? Other Medical Device Regulations World-Wide 6
E Obligations of Foreign Distributors of US Medical Devices US Food and Drug Administration (FDA) 1
K Multiple Distributors in Argentina Other Medical Device Regulations World-Wide 3
Y Thai FDA Medical Device Registration with 2 distributors Other Medical Device Regulations World-Wide 2
Buckyb Boeing QMS Requirements for Tier 2 Distributors AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 20
J Inspection Requirement For Medical Device Distributors Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
E Regulatory Requirements for Distributors of Medical Devices Other Medical Device Regulations World-Wide 6
J Tracking the End Customer by Distributors 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
S Internal Audits required before Registration Audit - Distributors ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
Q Are IVD Distributors subject to "Qualification" under our Quality System? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
A Supplier Evaluation Procedure in case of Agency (Distributors) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
Q Should distributors be also certified to IS0 9001? IATF 16949 - Automotive Quality Systems Standard 16
Q How can Six Sigma be implemented in Retail Distributors (Logistics and Supply Chain) Six Sigma 4
B Sticker with Distributors Logo according CE requirements (Medical Devices) CE Marking (Conformité Européene) / CB Scheme 6
B Supplier Approval for Distributors of Equipment Misc. Quality Assurance and Business Systems Related Topics 5
1 Third Party Certifications - Certificate of Compliance for Distributors Document Control Systems, Procedures, Forms and Templates 2
arios Selection and Control over Distributors of Components for Medical Devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
I Do company sales agents/distributors need to go through supplier evaluation process? Other Medical Device and Orthopedic Related Topics 5
M Canadian Registration & the Responsibilities of Distributors Canada Medical Device Regulations 12
G PPAP to distributors or catalog parts??? APQP and PPAP 9
T Measuring Quality Performance of Distributors - Product defects Supplier Quality Assurance and other Supplier Issues 2
Sidney Vianna AS/EN 9120:2009 for Distributors - News from the IAQG website AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
Q Supplier Control for Wholesale Distributors ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
A Assessment of Distributors and/or Distributors cum Manufacturers. ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M Return Goods Policy to Provide to Our Distributors ISO 13485:2016 - Medical Device Quality Management Systems 1
GStough Identification & Traceability - ISO13485:2003 - Clause 7.5.3.2 - Distributors ISO 13485:2016 - Medical Device Quality Management Systems 4
J Return of Product from Distributors / Hospitals - ISO13485 - Not necessarily recall Hospitals, Clinics & other Health Care Providers 2

Similar threads

Top Bottom