Brazil Sanctions for Health Offenses under Lei 6.437/1977

1. Key takeaways

The statutory source of sanctions for health offenses in Brazil is Lei 6.437/1977 (dated August 20, 1977 and published in the DOU on August 24, 1977, Part 1, page 11145). Fines are set according to the infraction level (leve / grave / gravíssima), with specific amounts under the current rules [the original was priced in 1977 cruzeiros; this series does not list amounts], alongside eleven categories of sanctions including warnings, seizure, destruction and product interdiction. GRZAN’s judgment: companies going abroad tend to focus only on getting registered while underestimating the post-market sanction exposure — Article 85 of RDC 848/2024 and Article 15 of IN 426/2026 both route violations of the new rules into this law.

2. Legal basis

• Law on health offenses and sanctions — Lei nº 6.437/1977, dated August 20, 1977 and published in the DOU on August 24, 1977 (Part 1, page 11145), full text (list of sanctions)
• Essential safety and performance requirements — RDC nº 848/2024, resolution of March 6, 2024, published in the DOU on March 8, 2024, effective 180 days after publication (Article 88), effectiveness announcement issued by ANVISA on September 10, 2024, Article 85
• Transmission and management of the UDI database SIUD — IN nº 426/2026, published in the DOU on February 18, 2026, effective March 1, 2026 (Article 16), Article 15
• Operating conditions for companies subject to health licensing — Decreto nº 8.077/2013, signed on August 14, 2013, published in the DOU on August 15, 2013 (Seção 1, p.18) and in force on that date (Article 26), Article 15, §1 (registered licensed companies, manufacturers or importers must assure and maintain product quality, safety and efficacy up to the final consumer), Article 24 (natural persons, legal persons and technical and legal representatives bear civil and administrative liability under Lei nº 6.437/1977), Article 25 (repeals Decreto nº 79.094/1977 and Decreto nº 3.961/2001)
• Creation and competencies of the Brazilian Health Regulatory Agency — Lei nº 9.782/1999, published January 26, 1999, Article 7 (list of ANVISA competencies)
• Classification, notification and registration of medical devices, and labeling and instructions-for-use requirements — RDC nº 751/2022, resolution of September 15, 2022, Article 39 (as amended by RDC nº 777/2023, resolution of March 1, 2023, in force the same day) [verification level: existence of RDC 777/2023 confirmed via the Brazilian government’s WTO TBT notification; article-by-article content is second-hand — check against the DOU original]

3. Expert insights

The eleven categories of sanctions deserve to be read item by item: warning (advertência); seizure (apreensão); destruction (inutilização); product interdiction (interdição de produto); suspension of manufacturing and sale (suspensão de fabricação e venda); cancellation of the marketing authorization (cancelamento de registro); partial or total interdiction of the establishment (interdição parcial ou total do estabelecimento); prohibition of advertising (proibição de propaganda); cancellation of the company’s operating authorization (cancelamento de autorização de funcionamento da empresa); fine (multa, set according to the infraction level [the original was priced in 1977 cruzeiros; this series does not list amounts]); and cancellation of the establishment licensing permit (cancelamento do alvará de licenciamento de estabelecimento). GRZAN’s reading: the list escalates from correction to disqualification, and what truly threatens business continuity is the disqualification-type sanction. The eleventh category is most often omitted in secondary sources, yet it connects with the dual-track system of Article 2 of Decreto 8.077/2013 — the federal AFE and the local health license are two separate certificates, and the sanctions law reserves one category for the local permit.

The second insight is that the connection surface keeps widening. Article 85 of RDC 848/2024 routes violations of the ESPR into Lei 6.437/1977; Article 15 of IN 426/2026 likewise qualifies SIUD non-compliance as a health offense. GRZAN’s judgment: Brazil is using the same old law to carry new rules — obligations grow while the sanction basis stays unchanged, so companies can manage everything through a single obligation-to-sanction mapping table.

The third insight is the source of the powers. Within the competency list of Article 7 of Lei 9.782/1999, ANVISA may order sealing, sales bans, cancellation of operating authorization and other measures. The sanction list answers what happens if you do wrong; the competency list answers what ANVISA can do — together they form one complete chain of responsibility.

The fourth insight is the sequence of sanctions and correction. A warning is corrective in nature and can usually be eliminated within the remediation period; suspension of manufacturing and sale and cancellation of the marketing authorization directly affect supply. On receiving a notice of intended sanction, first determine whether it is corrective or disqualifying: the former is closed through remediation, the latter requires preparing supply alternatives at the same time.

As for when ANVISA presses the pause button, Article 39 of RDC 751/2022 (as amended by RDC 777/2023) narrows the situations that can lead to suspension of manufacturing, import, distribution, sale or use, covering four cases: product violations posing a health risk, violations in the manufacturing process, missing conformity certificates, and non-conformity with approved conditions. GRZAN’s judgment: what the four cases share is the need for objective evidence rather than mere complaints, and companies can use a self-check table to eliminate them in advance. [Verification level: article-by-article content of RDC 777/2023 is second-hand; existence confirmed via the Brazilian government’s WTO TBT notification — check the text against the DOU original.]

The fifth insight is the value of records. Sanction procedures are built on findings of fact; vigilance, remediation and internal approval records become procedural materials, so records management should be invested in as compliance infrastructure, not patched up afterwards.

The sixth insight is the knock-on effect of disqualification sanctions. Article 11 of RDC 751/2022 sets marketing authorization validity at 10 years, counted from the DOU publication date and renewable consecutively; once cancelled, the renewal path is interrupted with it. GRZAN treats this as the true cost of a disqualification sanction.

The seventh insight is where liability lands, and the decree level gives the most direct answer: Article 24 of Decreto 8.077/2013 provides that natural persons, legal persons and technical and legal representatives bear civil and administrative liability for health offenses under Lei 6.437/1977. GRZAN’s warning has three layers: liability is named down to the technical representative and the legal representative individually, not only the company; Article 15, §1 lists the registered licensed company, the manufacturer and the importer together as parties responsible for quality, safety and efficacy; the foreign factory, though not a direct sanction target, bears indirect pressure through the holder’s recourse claims and commercial terms — negotiate the allocation clauses in advance.

The eighth insight is the decree-level periodization. Article 25 repeals Decreto 79.094/1977 and Decreto 3.961/2001. The decree governs company authorization, establishment licensing, product registration and import — the sanction chain starts at the access stage; compliance documents still citing the old numbers should be updated in step.

4. Practical recommendations

• Build an obligation-to-sanction mapping table covering registration, vigilance, UDI and ESPR obligations.
• Rank disqualification sanctions (sales suspension, cancellation of the marketing authorization, cancellation of the operating authorization) as the number-one risk.
• Assess fine exposure along the upper edge of the infraction levels (leve / grave / gravíssima) [the original was priced in 1977 cruzeiros; this series does not list amounts].
• State recourse and cooperation clauses between holder and factory clearly in the agreement.
• For disqualification risks, prepare supply alternatives and customer communication plans in parallel.
• Archive vigilance, remediation and internal approval records together as procedural materials.
• Run a quarterly self-check against the four situations of Article 39 of RDC 751/2022.

5. Verification checklist

• □ Verify that the eleven sanction categories are cited completely (including the eleventh, cancellation of the establishment licensing permit)
• □ Verify the current text setting fines according to the infraction levels (leve / grave / gravíssima)
• □ Verify the links in Article 85 of RDC 848/2024 and Article 15 of IN 426/2026
• □ Verify the liable parties (holder / AFE-licensed company / technical representative RT)
• □ Verify the classification of any notice of intended sanction and the response path
• □ Verify that records archiving covers vigilance, remediation and approvals
• □ Verify the executability of supply alternatives
• □ Verify the current text of Article 39 of RDC 751/2022 (including the RDC 777/2023 amendment)
• □ Verify the current text of Lei 6.437/1977 against Planalto
• □ Verify that internal compliance documents no longer cite Decreto 79.094/1977 or Decreto 3.961/2001

Regulatory information verified as of October 29, 2026

GRZAN Regulatory Team

GRZAN helps manufacturers see the sanction exposure behind every Brazilian obligation: obligation-to-sanction mapping under Lei 6.437/1977, disqualification-risk contingency planning, records systems that stand up in sanction procedures, and defense support when ANVISA comes knocking. For sanction-risk management and inspection defense in the Brazilian market, contact info@grzanglobal.com.