Canadian Med Device distributors per MDSAP need to be treated as suppliers...

Do medical device companies need to have Canadian distributors on their approved supplier list?

I recalled seeing something in the MDSAP Audit guide (which covers Canadian regs) and found:

Verify that the roles and responsibilities of any regulatory correspondents, importers, distributors, or providers of a service are clearly documented in the medical device organization’s quality management system and are qualified as suppliers and controlled, as appropriate.

So I'd say yes, distributors should be qualified and approved (the requirement of a "list" can be argued).

yodon said:

I recalled seeing something in the MDSAP Audit guide (which covers Canadian regs) and found:

Verify that the roles and responsibilities of any regulatory correspondents, importers, distributors, or providers of a service are clearly documented in the medical device organization’s quality management system and are qualified as suppliers and controlled, as appropriate.

So I'd say yes, distributors should be qualified and approved (the requirement of a "list" can be argued).

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Thank you for your reply! Always appreciated.

Good info above. In your supplier management playbook, your org needs to have a QualityAgreement template tailored for distributors. Who does what?

Note: distributors are seen as a supplier of a service. Specifically (and obviously) the distribution of your goods, but related to that also as important parties to downstream traceability, possibly maintainers of conditions for quality in transit/storage, upstream complaint receipt & forwarding (especially due to vigilance obligations as well as post-market surveillance information), downstream field safety notice and field safety corrective action reach. Possibly also involved in translation.

William55401 said:

Good info above. In your supplier management playbook, your org needs to have a QualityAgreement template tailored for distributors. Who does what?

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Fully agreed. My organization has such things in place. We have been challenged by an external auditor on Canadian and US distributors, stating they should be treated the same. Is it considered common practice to have all distributors-regardless of location, on our approved supplier list?

Distributors should be qualified and approved with an agreement.
The agreement should mention that the Medical Device Establishment License obligations for the distributor.
I have been to some MDSAP audits where the distributor did not have an MDEL and the company had to stop distributing the devices.,