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MDSAP Companion and HC requirements


Involved In Discussions
The MDSAP Companion document states where to find each Clause and Regulation under each requirement for different participating countries, however it does not list the sections or guidance documents where to find the regulations for Health Canada. In particular the companion document states - Audit task 5. Determine the extent of outsourcing of processes that may affect the conformity of product with specified requirements and verify the proper documentation of controls in the quality-management system.

Clause and Regulation: [ISO 13485:2016: 4.1.5, 4.2.1; TG (MD)R Sch3 P1 1.4(5) (b)(iii), (d)(ii); RDC ANVISA 16/2013: 2.5; MHLW MO169: 5, 6; 21 CFR 820.50]

Additional country-specific requirements:

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

There is no reference to where this requirement can be found. Does anyone know where I can find this requirement. I was told that not all the perceived requirements in the Companion Document for HC is actually a requirement??? Thanks!

Marcelo Antunes

Addicted to standards
Staff member
MDSAP only has regulatory requirements, not guidance (beucause their are guidance, and MDSAP is used to comply with regulatory requirements).

I don't remember it right now and can't search now, but the mentioned requirement is probably in the Health Canada registration requirements (MDL and MDEL).
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