All: I implemented a 13485 quality management system at our facility in RI. We now are beginning to work on a bid for a medical xray camera for a Canadian customer. I am currently both QA and Operations and will be until we can staff up.

I need help understanding the CMD CAS portion. If we have no exclusions in our scope of 13485 what is needed to satisfy CSA if any? Last year our registrar was pleased with our systems but said we needed to work on it to meet CMD CAS. Not sure where he was going with that?

Can you help me understand it, provide me literature or a location for literature etc....??? Thanks for the help. Peace: e3

Can you help me understand it, provide me literature or a location for literature etc....??? Thanks for the help. Peace: e3You can start here (http://www.hc-sc.gc.ca/dhp-mps/md-im/qualsys/index-eng.php).
Good luck.

Summary of the link: Quality Systems ISO 13485

Health Canada requires medical device manufacturers to use a quality system certificate as evidence of compliance to the appropriate regulatory quality system requirement. Health Canada will only accept quality system certificates that have been issued by special third party auditing organizations called Canadian Medical Devices Conformity Assessment System (CMDCAS) recognized registrars. The Medical Devices Regulations do not require importers or distributors of medical devices to have a registered quality system.

The Medical Devices Regulations require class II, III and IV medical devices to be manufactured (class II) or designed and manufactured (class III & IV) under CAN/CSA ISO 13485:2003. There are no regulatory quality system requirements for Class I medical devices. These quality system requirements came into force on January 1, 2003.

So by reading this, I take away the main point that for the importing medical devices into Canada customers may require that the Quality Management System as implemented at the Supplier (us) to be certified by a 3rd party registrar that is recognized by CMD/CAS.

If that is true, we use KEMA medical and they are recognized as CMD/CAS as per the certificate they provided for our ISO13485.

......If that is true, we use KEMA medical and they are recognized as CMD/CAS as per the certificate they provided for our ISO13485.

Yes, you can.

Also check with them.

I would recommend that you download a copy of GD210 which you can find easily as the Health Canada Guidance document for ISO 13485:2003.

In GD210, there is a table with all the clauses of ISO 13485 along with the applicable Canadian Medical Device Requirements, and questions that should be asked by the auditors.

It is the most useful document when implementing the Canadian Medical Device Regulations.

In addition to the document that Danny recommended, the link is - ANNEX A - Links Between ISO 13485:2003 and MDR (http://www.hc-sc.gc.ca/dhp-mps/md-im/qualsys/cmdcas_scecim_audit13485_2-eng.php#anna)

The entire GD 210 document in pdf can be viewed HERE (http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/md-im/cmdcas_scecim_audit13485_2-eng.pdf)

This document is contained within the link that Sideny provided earlier.

All: That link of annexes is awesome. Thanks for the documentation. Looks like I have some reading to see what they may ask. Thanks again all. Peace: e3