MDSAP Audit Approach (MDSAP AU P0002)
Chapter 4: Medical device adverse events and advisory notices reporting – MDSAP Audit Approach (MDSAP AU P0002)

MDSAP Audit Approach (MDSAP AU P0002) C4-T2-JP: Japan: as a Registered Manufacturing Site, maintain effective communication with the marketing authorization holder on advisory notices so the holder can report them

What does C4-T2-JP require?

Marketing authorization holders report advisory notices to the Japanese regulator (PMD Act 68-11). A person operating a Registered Manufacturing Site does not report directly but must set up and use effective arrangements to communicate with the holder about advisory notices so it can take the necessary regulatory action (MO169 Art 29).

Maintained by Gerard Blokdyk

Other controls in Chapter 4: Medical device adverse events and advisory notices reporting – 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