ANVISA SaMD: your healthcare software correctly classified and authorised.

We manage Software as a Medical Device (SaMD) authorisation with ANVISA, from determining whether it qualifies as a device to risk classification and the technical dossier, aligned with IEC 62304 (software lifecycle) and appropriate treatment of artificial intelligence solutions.

Speak to a specialist See what we deliver
ANVISA SaMD: your healthcare software correctly classified and authorised.
What we deliver

We translate your software into regulatory terms and guide it through the correct registration pathway.

  1. Determining whether software qualifies as SaMD under ANVISA and IMDRF criteria.

  2. Risk classification and selection of the authorisation pathway.

  3. A technical dossier with lifecycle evidence (IEC 62304) and risk management (ISO 14971).

  4. Usability (IEC 62366) and cybersecurity considerations.

  5. Support for SaMD using AI/machine learning, including change control.

Deliverables

What you receive

A regulatory assessment and SaMD classification report.
A software technical dossier ready for submission.
IEC 62304 lifecycle documentation and a risk management file.
SaMD registration/notification followed through to approval.
References

Reference standards

  • RDC 751/2022 - classification and market authorisation (applied to SaMD).
  • IEC 62304 - medical device software lifecycle.
  • ISO 14971 and IEC 62366 - risk management and usability; IMDRF SaMD framework.
FAQ

Frequently asked questions

Let's talk

Have healthcare software and unsure whether it needs registration?

We assess its regulatory status and guide your SaMD through ANVISA.

Speak to a specialist

Or leave your details and we will get back to you:

We have received your details.

Our team will contact you shortly. Thank you!