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Life Sciences & Healthcare Newsletter | March 2026
April 15th, 2026
The Life Sciences and Healthcare Newsletter provides for monthly updated information on the main topics, laws, and standards related to the life sciences and healthcare sector in Brazil and is an opportunity to access legal information and comments on relevant market issues.
Enjoy reading!
Demarest’s Life Sciences and Healthcare Team
This material is for informative purposes only, and should not be used for decision-making. Specific legal advice can be provided by one of our lawyers.
CFM issues resolution on AI use in medicine
On February 27, 2026, the Brazilian Federal Council of Medicine (“CFM”) published CFM Resolution No. 2,454/26, which regulates the use of artificial intelligence (“AI”) in medicine. The resolution will enter into force 180 days after its publication.
According to the CFM, the resolution is the result of a year and a half of debates conducted within the working group established to discuss the incorporation of AI into medicine.
The initiative seeks to respond to the growing use of AI in medical practice and ensure compliance with the principles of beneficence, non-maleficence, medical autonomy, justice, and patient-centered care.
The new regulatory framework, however, is not limited to clinical practice. It has significant implications for healthcare institutions, technology companies, software developers, research sites, and other stakeholders within the digital health ecosystem. As such, it requires a structured approach to governance, data protection, and intangible asset management.
See our Client Alert for more details.
New law authorizes the sale of medicines in supermarkets
On March 23, 2026, Law No. 15,357/2026 was published, authorizing the sale of medicines in supermarkets and expanding the channels for dispensing and marketing medicines, including through digital channels and e-commerce platforms, thereby facilitating consumer access to pharmaceutical products.
See our Client Alert for more details.
- MS-ANVISA Ordinance No. 361/2026 – Establishes a working group to coordinate the review of Annex IV of Collegiate Board Resolution (RDC) No. 67, dated October 8, 2007, which provides for Good Compounding Practices for Sterile Products in pharmacies.
- ANVISA Normative Instruction No. 428/2026– Updates the Reference Listed Drugs (“LMR”) in Brazil.
- ANVISA Normative Instruction No. 429/2026: Provides for the update of the composition of COVID-19 vaccines to be used in Brazil.
- Normative Instruction No. 430/2026 – Amends ANVISA Normative Instruction No. 106/2021, which establishes the list of low-risk medicines subject to notification.
- ANS Normative Resolution No. 666/2026 – Provides for technical-assistance visits (conducted at the operator’s premises) to identify serious administrative irregularities in healthcare plan operators.
- COFEN Resolution No. 803/2026 – Updates the Annex to Cofen Resolution No. 728, dated November 9, 2023, which regulates the activities of rehabilitation nursing teams.
CLINICAL RESEARCH WITH HUMAN SUBJECTS
- MS-GM Ordinance No. 264/2026 – Appoints the full-time and alternate members of the National Research Ethics Body (“Inaep”) within the scope of the Ministry of Health.
- SCTIE/MS Notice No. 1/2026 – Establishes the rules of the public selection of scientific community representatives for the Inaep bench, pursuant to article 12, item VII, and articles 13 and 14 of Decree No. 12,651/2025.
- Decree No. 12.881/2026 – Approves the organizational structure and staffing framework of the Brazilian Data Protection Authority (ANPD) and reallocates and transforms commissioned positions and trusted roles.
- SEIDIGI/MS Ordinance No. 19/2026 – Establishes the Special Accreditation Committee, responsible for processing and adjudicating applications submitted by private healthcare establishments, for profit or not, for contracting by states, municipalities, and the Federal District of telehealth services under the modalities provided for in the SUS Digital Telehealth Strategic Action, within the scope of the SUS Digital Program, pursuant to Notice No. 2/2025.
- MS-SAES Ordinance No. 3,943/2026 – Provides for the intervention of the Ministry of Health in contracts entered into by federative entities, exclusively within the scope of Law No. 15,233/2025, which instituted the Agora Tem Especialistas Program; and provides contract templates.
- MS-SAES Ordinance No. 3.949/2026 – Includes a procedure and amends attributes of procedures that are part of the outpatient component of the Agora Tem Especialistas Program, in the SUS Table of Procedures, Medicines, Orthoses, Prostheses, and Special Materials.
- MS-SAES Ordinance No. 3.951/2026 – Amends SAES/MS Ordinance No. 3,199/2025, SAES/MS Ordinance No. 3,200/2025, and SAES/MS Ordinance No. 3/2025, all related to the operation of the Agora Tem Especialistas Program.
- MS-SAES No. 3.935/2026– Provides for the operationalization, within information systems, of the recording of production carried out under the concentrated strategy to expand access to specialized care within the SUS, with a focus on women’s health, within the scope of the Agora Tem Especialistas Program.
SOCIAL CONTRIBUTIONS
ANS Public Consultation No. 170/2026 – Aimed at obtaining contributions from civil society and regulated entities regarding the proposal to unify and update the rules governing the execution of contracts between operators and healthcare service providers, replacing Normative Resolutions No. 503, dated March 30, 2022, and No. 512, dated March 31, 2022.
Contribution deadline: May 16, 2026
ANVISA Public Consultation No. 1.391/2026 – Proposal for international alignment of analytical method validation parameters for medicines, through the revision of RDC No. 166/2017.
Contribution deadline: June 01, 2026
ANVISA Public Consultation No. 1.392/2026 – Proposal for collegiate board resolutions on the coordination, structuring, organization, and execution of health oversight actions carried out by the federal government, the states, the Federal District, and municipalities.
Contribution deadline: July 04, 2026
