Policy ideaSeedPublic
Risk-based regulation for service robots in healthcare settings
A proportional regulatory path so logistics robots are not certified as clinical devices.
Structure
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- Problem
- Not yet defined
- Jurisdiction
- Brazil (federal, ANVISA)
- Policy instrument
- RDC amendment creating a logistics-robot class
- Stakeholders
- ANVISA, hospital associations, robot operators, nursing councils
- Expected impact
- Certification cost −60% for logistics-only robots.
- Evidence base
- Not yet defined
- Legal basis
- Not yet defined
- Implementation path
- Not yet defined
- Risks
- Not yet defined
Assumptions
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