Subcontractor in terms of CAN/CAS 13485:2003 CMDCAS vs. DIN EN ISO 13485:2003

[leon76]

Hello,
together. I need help. I come from Germany and work by one medical device manufacturer. Our company has certificate DIN EN ISO 13485:2003 and compliance of the quality management system with Annex II of the council directive 93/42/EEC concerning medical devices . We produce for one our client two medical device products. We are original equipment manufacturer. Our customer is private label manufacturer and manufacturer in terms of 93/42/EEC and he has the product license from Health Canada. He is certificated by one canadian registrar to CAN/CAS 13485:2003. Should we need us to certificate to CAN/CAS 13485:2003 too? Is it required for us? What is the requirement from CAN/CAS 13485:2003 for subcontractors?
I think this requirement is satisfied with our DIN EN ISO 13485:2003.

 

[Al Rosen]

Hello,
together. I need help. I come from Germany and work by one medical device manufacturer. Our company has certificate DIN EN ISO 13485:2003 and compliance of the quality management system with Annex II of the council directive 93/42/EEC concerning medical devices . We produce for one our client two medical device products. We are original equipment manufacturer. Our customer is private label manufacturer and manufacturer in terms of 93/42/EEC and he has the product license from Health Canada. He is certificated by one canadian registrar to CAN/CAS 13485:2003. Should we need us to certificate to CAN/CAS 13485:2003 too? Is it required for us? What is the requirement from CAN/CAS 13485:2003 for subcontractors?
I think this requirement is satisfied with our DIN EN ISO 13485:2003.

As I understand it, you are strictly a sub-contractor and your customer has the license in Canada. In this case, I believe, you do not have to be registered by a CAMDCAS (Canadian Medical Devices Conformity Assessment System) Registrar. Your customer is the manufacturer and is responsible. From the regulation:

"manufacturer" means a person who sells a medical device under their own name, or under a trade-mark, design, trade name or other name or mark owned or controlled by the person, and who is responsible for designing, manufacturing, assembling, processing, labelling, packaging, refurbishing or modifying the device, or for assigning to it a purpose, whether those tasks are performed by that person or on their behalf.

You can find more information on the Health Canada website.

 

[leon76]

Hello Al Rosen. Thank you very much for your quickly answer. Yes, you're right. What do think about:

I add to this question a checklist from our customer. What do you think about the question 0.1.6, 0.1.7, 0.1.8, 0.1.9, 0.1.11.?

Is it concerned us?

Thank's.

 

[Al Rosen]

Hello Al Rosen. Thank you very much for your quickly answer. Yes, you're right. What do think about:

I add to this question a checklist from our customer. What do you think about the question 0.1.6, 0.1.7, 0.1.8, 0.1.9, 0.1.11.?

Is it concerned us?

Thank's.

I'm not sure what you mean by "Is it concerned us?", but since you are not registered by a CMDCAS Registrar, your customer will want you to be willing to allow an audit by their CMDCAS Registrar. Just because you will permit it, I don't know that they will do it. The CAMDCAS requirements are concerned mostly with Labelling, Complaint Handling, Problem Reporting and Recalls. Your customer is responsible for this as the manufacturer. If you are registered to ISO 13485, I think you will be OK.

I've posted the Canadian Medical Device Regulation in this thread and there are more guidance documents on this Health Canada web page.

 

[leon76]

Okay, i know the documents. I've read the thread 7145.
Thank's.
What do you think about the question 0.1.6, 0.1.7, 0.1.8, 0.1.9, 0.1.11.?
Is it applicable for us (OEM-manufacturer)? The checklist is from the notified body of our customer. I am not sure if the questions concerned us and didn't think so.
Goodnight! See you tomorrow!

 

[Al Rosen]

Okay, i know the documents. I've read the thread 7145.
Thank's.
What do you think about the question 0.1.6, 0.1.7, 0.1.8, 0.1.9, 0.1.11.?
Is it applicable for us (OEM-manufacturer)? The checklist is from the notified body of our customer. I am not sure if the questions concerned us and didn't think so.
Goodnight! See you tomorrow!

The one thing that is not clear to me is, who is to complete this list, you or your customer? Based on what you described, I think they are applicable if your customer is to complete it. How would your customer answer them? Here's what I think based on your description:

0.1.6. Is there a subcontractor who has a substantial involvement with the manufacture ore design and manufacture of the concerned devices?

Yes

0.1.7. Is there a subcontractor who is undertaking the supply of a part, material or service which may affect the conformance of the Medical Device with the safety and effective requirements of the MDR?

Yes

0.1.8. (only if 0.1.6 or 0.1.7 appropriate) Has the subcontractor an effective quality system that has been audited by another CMDCAS recognised registrar?
(If true, please give a copy of the valid certificate covering the parts, services, materials or finished devices concerned to DQS Frankfurt)

No

0.1.9. (only if 0.1.6 or 0.1.7 appropriate and 0.1.8. is not appropriate) Has the legal manufacture control about its subcontractor that could include the following:
(i) specifying design and product requirements?
(ii) Specifying personnel qualification?
(iii) Verifying that subcontracted products meet specified requirements?
(iv) Performing on-site inspections?
(v) Validating processes?

Who does these, you or your customer? If your customer is not maintaining enough control, then 0.1.11 may apply.

0.1.11. (only if 0.1.6 or 0.1.7 appropriate and 0.1.8. is not appropriate)
Has the manufacture the permission by the subcontractor (according 0.1.6) to allow DQS as a CMDCAS recognised registrar to undertake an audit or assessment of the relevant sites of the subcontractor?

If I were your customer, I would include in our contract a statement that would stipulate that you could be subject to an audit by my registrar. Whether you will be audited, is another subject.

What would your answers be if you are required to complete the check list?

The purpose of these questions is to determine if you have a sub-contractor that is not registered to the CAMDCAS requirements. If so, then you must control your sub-contractor. If I were you I would add the statement in your contracts or purchase orders that by acceptance of the contract, the sub-contractors & suppliers may be subject to an audit by a third party.