Brazil · Advertising framework
Print advertising and advertorials for digital health products in Brazil
General market orientation, not campaign clearance. Research scope and dates
Product and service rules
Medical-purpose software needs a separate classification check
Regulator guidance
ANVISA distinguishes medical-purpose software from general wellness and administrative functions. Identify the advertised function and the applicable device regularisation. Do not use a wellness description to bypass review of a diagnostic or therapeutic claim.
Sources: Medical equipment regularisation manual; Software as a medical device: questions and answers
Channel rules
Check the complete consumer-facing message
Regulator guidance
Consumer advertising must be identifiable and must not be misleading or abusive, including through omission. Keep the factual, technical and scientific basis for the message. Review service promises, product claims, price conditions and imagery together; an influencer label does not remove these obligations.
Review at final printed size
Editorial recommendation
Approve the advertorial label, full layout and legibility at actual size. Check what must appear in the advertisement itself before moving details behind a QR code.
Campaign workflow
Digital Health Products: prepare the review
Editorial recommendation
Classify each software function separately: lifestyle, medical software or delivery of care. Link accuracy and clinical outcome claims to the advertised software version and population. Review tracking and marketing data flows separately from permission to provide care.
Keep a traceable campaign decision
Editorial recommendation
Keep one review record linking the offer, local market status, claim evidence, exact creative, media settings and any regulatory or professional clearance. Record who checked each condition. Reopen the review when the offer, claim, source rule or execution changes.
Pre-publication checklist
- Classify each software function separately: lifestyle, medical software or delivery of care.
- Link accuracy and clinical outcome claims to the advertised software version and population.
- Review tracking and marketing data flows separately from permission to provide care.
- Record product or provider eligibility before approving claims.
- Archive the final creative and its evidence, permissions and review decisions.
- Assign an owner for source updates, complaints and prompt withdrawal of inaccurate material.
Scope and unresolved questions
- CFO patient-image conditions and the IVD-specific RDC 830/2023 route are now documented. The final effect of RDC 96 litigation remains unverified. Actual court orders, state/municipal licences, pharmacy codes, product warning assets and the legal basis for direct marketing still require a campaign review.
- This national baseline does not review every broadcaster rule, platform policy, regional licensing condition, promotion mechanic or data-transfer arrangement. No format-specific warning dimensions or durations should be inferred where none are supplied.
Research scope, introduction and dates
A digital-health offer promoted in print campaigns in Brazil may combine a lifestyle function, medical software and a clinical service. Identify each advertised function and software version, then review clinical claims and the use of personal data separately.
Printed advertisements must work at their final physical size. Review the advertorial label, required information, images and multipage layout together, including what stays on the page when a QR code points readers elsewhere.
General market orientation, not legal, regulatory or medical advice, a complete compliance plan or clearance of an advertisement. Actual requirements depend on the specific offer and campaign.
How to use this national baseline
Editorial overview
This framework combines researched national rules with editorial review steps. Federal ANVISA and professional advertising baseline; local licences and professional scope require individual checks. A visible channel workflow does not establish that the selected product or service may be advertised there. Read the category restrictions first.
The review date identifies when the cited provisions or regulator excerpts were checked. It does not mean that every local rule, exception, professional standard or platform policy has been reviewed.
Sources
- Medical equipment regularisation manual
Targeted source review; apply the cited provision to the exact offer and check subsequent changes before launch.
- Software as a medical device: questions and answers
Targeted source review; apply the cited provision to the exact offer and check subsequent changes before launch.
- Consumer Protection Code, Lei 8.078/1990
Targeted source review; apply the cited provision to the exact offer and check subsequent changes before launch.
From framework to action
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