MDSAP Audit Approach (MDSAP AU P0002)
Chapter 1: Management – MDSAP Audit Approach (MDSAP AU P0002)

MDSAP Audit Approach (MDSAP AU P0002) C1-T10: Distribute or offer devices only into markets where they hold the required marketing authorization, and license and label private-label devices for Canada correctly

What does C1-T10 require?

Controls must ensure that a device is distributed or offered only once it holds the marketing authorization that market requires for commercial distribution in each market. Australia: ARTG inclusion is solely the sponsor's responsibility, so there is nothing to audit here for Australia. Canada: where the site makes private-label devices for Canada, each must be licensed for sale and labelled with the name, address and identifiers of the private-label licence holder. Clauses: ISO 13485:2016 4.1.1, 4.2.1, 5.2, 7.2.1, 7.2.3.

Maintained by Gerard Blokdyk

Other controls in Chapter 1: Management – MDSAP Audit Approach (MDSAP AU P0002)

Query this from an agent

The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.

MCP endpointAll MDSAP Audit Approach (MDSAP AU P0002) controls