Docs of the Month: Brazil Answers 133 Software Questions

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In this month’s spotlight from Pathways’ Document Depot: Brazil’s ANVISA provides strikingly specific answers to 133 stakeholder questions about its regulation of software as a medical device. And US FDA takes a slightly different approach in this rapidly evolving subsector of device regulation.

Docs of the Month is a regular column highlighting key findings from Pathways’ Document Depota database of global medtech regulatory and policy official documents, including rules, guidance documents, memos, white papers, and more from national authorities, non-governmental groups, and global organizations.

Marking the boundaries between where medical device regulation begins and ends, and between the levels of regulation devices will face based on risk, is not an exact science. The borderlines adjust as technologies continue to evolve along with the evidence supporting them and the level of comfort healthcare providers have in wielding them. And there is no segment of medtech where those boundaries are more unsettled than software.

The rapidly moving field of digital health creates shifting regulatory considerations for product developers. That aura of uncertainty and the significant energy being invested by agencies to try to clarify it are underscored in a document that was published in mid-October by the Brazilian Health Regulatory Agency (ANVISA). The Q&A-style guidance, intended to support the agency’s new Software as a Medical Device Regulation (RDC 657) that took effect in July, is our Doc of the Month for October (links in Portuguese). It includes responses to a whopping 133 questions about how different types of software fit, or don’t fit, into its framework and other regulatory considerations.


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