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ANVISA, CFM and ONA compliance hub

ANVISA, CFM and ONA guides

Each guide answers one question a provider in Brazil, worked through São Paulo and Rio de Janeiro asks about ANVISA, CFM and ONA, from the official sources it cites. There are 7 guides across 7 topics, last checked on 16 October 2026.

The depth of a licensing and accreditation readiness review, written from ANVISA's RDCs, the CFM's resolutions and ONA's own method. ONA's map lists 1,803 accredited organisations in 25 states. Each guide ends with how wai does the work.

Updated .

A man in a dark suit walking across a sunlit stone atrium, a tall tree growing inside under a wall of glassLicenceHow does a clinic get its licença sanitária in Brazil?Two colleagues smiling over a tablet behind a long oak reception desk in a tall, sunlit hall hung with paper lanternsRegistrationHow does a clinic register with the CRM and name a diretor técnico?A clinician in a white coat writing on a tablet in a curved armchair beside a tall window over a river in afternoon lightRecordsWhat must a clinic's prontuário contain under CFM and ANVISA rules?Two colleagues in conversation at a floor-to-ceiling window above an autumn park and a city skyline in the late afternoonSafetyHow does a clinic set up a Núcleo de Segurança do Paciente?A man reading a document at a long wooden table carved from a single trunk, a tall window onto green trees and towers behind himAccreditationHow does a clinic reach ONA Acreditado com Excelência?

More guides

  1. 16 Oct 2026What consent do telemedicine and AI need under CFM rules?Consent
  2. 16 Oct 2026How should a Brazilian clinic handle LGPD and a data incident?Data

How the guides map to the ANVISA, CFM and ONA framework

The hub sets out the 6 headings ANVISA, CFM and ONA work to, and the guides take them one task at a time.

The 6 headings on the ANVISA, CFM and ONA hub

  1. The licença sanitária and boas práticas, 6 requirements on the hub. Every health service needs a current licence from its state or municipal vigilância sanitária, displayed to the public, and must meet ANVISA's requirements for good operating practice under RDC 63/2011.
  2. Patient safety and adverse events, 6 requirements on the hub. Health services constitute a Núcleo de Segurança do Paciente, write a Plano de Segurança do Paciente and notify adverse events to ANVISA on a fixed clock, under RDC 36/2013. Individual consulting rooms are outside that RDC, and RDC 63/2011's safety measures apply to every service.
  3. CRM registration and the diretor técnico, 6 requirements on the hub. A private clinic providing medical care registers with the CRM of its state, renews its certificate every year, and names a diretor técnico who answers to the council and the authorities for how it runs.
  4. The prontuário, 6 rules on the hub. Every patient has one record, dated, timed and signed at each assessment, reviewed by a committee, available to the patient, and kept at least 20 years from the last entry.
  5. Telemedicine, AI and health data, 5 rules on the hub. The CFM sets the consent and record rules for telemedicine and, since August 2026, for AI in care. The LGPD treats health data as sensitive and sets a three working day clock for incidents.
  6. ONA accreditation, 5 levels on the hub. ONA accreditation is voluntary and runs in three levels, assessed by a credentialed accrediting institution that checks what the clinic says it does, what it does and what patients perceive.

The 7 topics the guides are filed under

  1. Licence, 1 guide and about 8 minutes of reading. The licença sanitária.
  2. Registration, 1 guide and about 8 minutes of reading. CRM registration and the diretor técnico.
  3. Records, 1 guide and about 9 minutes of reading. The prontuário.
  4. Safety, 1 guide and about 8 minutes of reading. The Núcleo de Segurança do Paciente.
  5. Accreditation, 1 guide and about 9 minutes of reading. ONA accreditation, levels 1 to 3.
  6. Consent, 1 guide and about 8 minutes of reading. Telemedicine, AI and consent.
  7. Data, 1 guide and about 8 minutes of reading. LGPD and data incidents.

Questions about the ANVISA, CFM and ONA guides

Which ANVISA, CFM and ONA guide should I read first?

Start with The licença sanitária, the first guide on this page, about 8 minutes of reading, filed under Licence. The other 6 each stand on their own, so take them in the order your own preparation needs.

How do these guides relate to the ANVISA, CFM and ONA hub?

The ANVISA, CFM and ONA hub sets out the 6 headings ANVISA, CFM and ONA work to and how wai evidences each one. Each guide goes one level down, to a single task, with steps to follow, a template to copy, answers to common questions and the sources behind it.

How current are the ANVISA, CFM and ONA guides?

Every guide shows the date its facts were checked against the official sources it cites. All 7 were checked on 16 October 2026, the same date the hub shows beside its Updated line.

Are the ANVISA, CFM and ONA guides legal advice?

They are guidance, not legal advice, written from what ANVISA, CFM and ONA publish, with a link to the source for each fact. Neither ANVISA, the CFM nor ONA endorses wai or any software, and the accreditation for your organisation is decided by ONA, through a credentialed accrediting institution.

How do I request a demo for ANVISA, CFM and ONA?

Request a demo from this page and it reaches the wai team with ANVISA, CFM and ONA already named, so the call starts from ANVISA, CFM and ONA rather than a general tour. You can also write to team@wellnessa-i.com.

The hub

  1. ANVISA, CFM and ONAWhich clinic software fits ANVISA, CFM and ONA rules?Hub

See wai on your own diary, notes and inbox.

Fifteen minutes on video, in Portuguese or English, on your own clinic's records.

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