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-BR: Brazil: define when field actions are needed, keep records of all field actions, carry them out on evidence of non-compliance or on ANVISA's demand, and notify ANVISA within the set deadlines

What does C4-T2-BR require?

Procedures must decide when a field action (recall or correction) is needed, within the post-market surveillance system (RDC 67/2009 Art 6; RDC 551/2021 Arts 1 and 5), and records must be kept of every field action, including those not reportable (RDC 551/2021 Arts 4, 6, 10, 11, 16). Field actions must be taken on potential or concrete evidence that a product does not meet essential safety and effectiveness requirements (Arts 4, 6, 7, 13 to 15). Domestic manufacturers and legal representatives must send ANVISA the reports it requests, perform field actions ANVISA requires and notify ANVISA within the regulation's deadlines (Arts 6 to 8, 10, 11); international manufacturers must make sure their Brazilian legal representative knows of field actions on products exported to Brazil.

Maintained by Gerard Blokdyk

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

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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