A post-market surveillance system must be part of the QMS, with procedures to identify adverse events promptly, investigate them and use the results to improve safety and effectiveness (RDC 67/2009 Art 6). Domestic manufacturers and legal representatives must have top management designate, in writing, a professional responsible for the system (Art 5). Complaints must be processed and recorded, investigated and answered to the complainant, or to the Brazilian legal representative for an international manufacturer (Arts 6, 7, 9). ANVISA must be notified of problems including critical or non-critical adverse events, technical defects in marketed products, anything that could seriously endanger public health and counterfeits, and international manufacturers must make sure their Brazilian legal representative knows of deaths, serious public health hazards or counterfeits involving exported products (Art 8).
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.