Device and contact characteristics
Evaluation begins with intended use, patient population, contact type, exposure duration and the device’s physical characteristics.
Biological safety · Regulatory strategy
Is your device ready for ISO 10993-1:2025?
The new edition reinforces biological evaluation as part of medical device risk management. Review your evidence, documentation and regulatory pathway before a gap becomes a delay.
10993-12025 edition
Materials
Patient contact
Scientific evidence
Biological safety is a regulatory strategy.
✓Aligned with ISO 14971 risk management
✓Evidence-driven evaluation
✓Focused on intended use and exposure
What manufacturers need to know
It takes more than a collection of tests.
ISO 10993-1:2025 places biological safety inside the broader risk-management process. The evaluation should justify decisions using the device, its materials, the nature and duration of contact, and the available scientific evidence.
Materials and available knowledge
Material composition, manufacturing information, chemical characterization and relevant literature should support the biological rationale.
A documented risk-based conclusion
Testing is one possible source of evidence—not the objective itself. Each decision should be traceable, justified and connected to risk control.
What this means for manufacturers
Documentation gaps can become regulatory obstacles.
01Legacy reports that are not clearly connected to the current device configuration.
02Biological endpoints selected without a documented risk-based rationale.
03Insufficient characterization of materials, processing residues or patient exposure.
04Risk-management documents and biological evaluation records that do not tell the same story.
RMG regulatory support
From technical evidence to a defensible strategy.
We help international manufacturers understand applicable requirements, assess existing evidence and organize the regulatory pathway for the Brazilian market.
Scope the device
Intended use, materials, configuration, contact profile and target market.
Review the evidence
Biological evaluation plan/report, test reports, characterization and risk files.
Map the gaps
Identify uncertainties, inconsistencies and missing justifications that may affect submission.
Build the pathway
Define priorities, supporting evidence and the regulatory plan for Brazil.
Brazil market readiness
A global standard.
A local regulatory pathway.
A strong biological evaluation is only one part of market readiness. RMG connects technical documentation to the applicable Brazilian regulatory strategy, helping your team move forward with clarity.
FAQ
Questions manufacturers are asking.
Does the 2025 edition mean every device needs new testing?
Not necessarily. The biological evaluation is evidence- and risk-based. Existing data may remain relevant when its applicability is adequately demonstrated; gaps and uncertainties should be evaluated case by case.
What should be reviewed first?
Start with the current device configuration, intended use, contact profile, material and manufacturing information, available chemical and biological evidence, and alignment with the risk-management file.
Can RMG perform a gap assessment?
RMG can assess the documentation made available, identify potential regulatory gaps and help structure an action plan aligned with the intended Brazilian market pathway.
Does ISO 10993-1 approval guarantee ANVISA registration?
No single standard guarantees market authorization. The applicable Brazilian requirements depend on the device, classification, intended use and regulatory route. RMG evaluates these elements together.
The next step starts with clarity
Is your biological evaluation ready for the next regulatory review?
Talk to Register Medical Group about your device, documentation and strategy for Brazil.