Brazil · Advertising framework
Email, SMS and direct-message marketing 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.
Health information has a sensitive-data regime
Regulator guidance
ANPD identifies health information as sensitive personal data under the LGPD. Determine an applicable Article 11 condition for that processing rather than relying automatically on an ordinary Article 7 marketing basis. Review patient stories, list building, tracking and sharing separately.
Sources: ANPD frequently asked questions
Separate promotional and service messages
Editorial recommendation
Review the rules for the actual delivery method: email, SMS and private social messages are not interchangeable. Keep the relevant permission record, accurate sender details and a working suppression process.
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 by email, SMS and direct messages 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.
Email, SMS and private platform messages can follow different permission rules. Identify the delivery technology and the recipient relationship, then review the promotional content and withdrawal process separately.
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.
- ANPD frequently asked questions
Targeted source review; apply the cited provision to the exact offer and check subsequent changes before launch.
From framework to action
Local expertise in Brazil
Find support with medical and health marketing, marketing and sales advice, or organizing your business and coordinating projects in Brazil.
Medical & health marketing
No partners listed in this category yet.
Marketing & sales advisory
No partners listed in this category yet.
Business & project coordination
No partners listed in this category yet.
Join the local partner directory
Would you like your company to be listed?
Talk to us about the terms of a listing. Leave your details and we will get in touch.