The Life Sciences and Healthcare Newsletter provides monthly updates on the main topics, laws, and standards related to the life sciences and healthcare sector in Brazil, and offers 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.

MAIN UPDATES

RDC 1.042/2026: ANVISA amends rules for transferring marketing authorizations of “clone medicines”

The Brazilian Health Regulatory Agency (ANVISA) has published a resolution amending the rules governing the transfer of marketing authorizations obtained through the simplified procedure—known as “clone registrations.”^[1] Under the new rule, medicines approved through the simplified procedure under Collegiate Board Resolution No. 31/2014 will remain linked to their respective parent authorization, even if ownership of the parent authorization is transferred to a company belonging to a different economic group. In such cases, the successor companies must ensure compliance with the applicable quality requirements.

In turn, a clone registration granted under RDC No. 31/2014 may only be transferred to a company in a different economic group than the parent marketing authorization holder when the transfer results from a merger, spin-off, consolidation, or corporate succession.

Ultimately, the new regulation has relaxed the requirement that both the clone and the parent authorization holders belong to the same economic group, specifically for authorizations granted under Collegiate Board Resolution No. 31/2014.

^[1]Collegiate Board Resolution No. 1,042/2026, published on September 18, 2026, amended Resolution RDC No. 954/2024.

INAEP publishes guidelines on the use of ai in clinical research

Brazil’s National Research Ethics Committee (INAEP) has published Guidelines for the Ethical Use of Artificial Intelligence in Research Involving Human Subjects. These guidelines assist in developing and ethically evaluating protocols that use AI systems—whether as the subject of research, a methodological tool, an analytical resource, a decision-making component, or content and inference generation mechanism.

The initiative is structured around three supplementary documents made available by INAEP:

• Main Guide
• Reference Handbook
• Risk Assessment Matrix for Artificial Intelligence in Research Involving Human Subjects (MARIAH)

This collection of materials provides institutional guidance, a technical and regulatory framework, and practical tools to support researchers, research institutions, and Research Ethics Committees. It aims to help identify, classify, document, and proportionately mitigate the risks associated with the use of AI in research involving human subjects.

The initiative reinforces that AI solutions should be used as support tools in accordance with the ethical principles governing clinical research, the protection of personal data, and the safety of subjects.

ANVISA temporarily suspends technical note on beauty services

ANVISA has ordered the temporary suspension of Technical Note No. 2/2024, which provided guidelines on the classification of beauty and aesthetic services, the applicable health requirements, and the use of products and procedures in these establishments.

The measure followed the formation of a working group to reassess the sector’s regulatory and health-related aspects and to review previous decisions issued by ANVISA.

ANVISA emphasized that the technical note was for informational purposes and did not establish any independent rights or obligations. The suspension aims to ensure institutional consistency and legal certainty while the matter is under technical review, without waiving compliance with the applicable legal and regulatory standards for aesthetic services.

Companies and professionals in the sector should monitor developments in this matter, as the temporary suspension of the technical note signals the start of a regulatory debate over the boundaries of services provided in beauty establishments. The reassessment may result in the technical note being maintained, revised, or replaced.

ANVISA proposes regulatory review on the reprocessing and reuse of medical devices

ANVISA has launched four public consultations^[2] to propose a comprehensive review of the regulatory framework governing the reprocessing of medical devices used in healthcare. These proposals stem from a regulatory process initiated more than a decade ago to update standards in force since 2006 and align Brazilian regulations with modern technologies and international regulatory practices.

The proposals are built upon four pillars:

• Good practice requirements for the reprocessing of medical devices in healthcare facilities;
• Requirements applicable to reprocessing companies;
• Guidelines for the validation, monitoring, and control of cleaning, disinfection, and sterilization procedures; and
• Criteria for classifying medical devices as “single-use” or “reusable.”

The proposals also increase requirements related to traceability, quality management systems, technovigilance, and the assignment of responsibilities throughout the processing chain.

Key discussion points include objective criteria to limit device reuse, more detailed information in labeling and instructions for use, and an ANVISA Operating Permit (AFE) for reprocessing companies. ANVISA also proposes consolidating the validation of cleaning, disinfection, and sterilization procedures as a key component of regulatory oversight and patient safety.

This regulatory initiative affects the medical device sector, healthcare facilities, and companies specializing in the reprocessing of these devices.

The public consultations will remain open for contributions until January 28, 2027.

^[2]Public Consultations Nos. 1,420, 1,421, 1,422, and 1,423.

New law establishes a national strategy for assessing the quality of private healthcare

Law No. 15,524/2026 has been enacted, establishing the National Strategy for Quality Control and Evaluation of Healthcare Services Provided by Private Healthcare Providers. The new law empowers ANVISA to set national quality standards and qualification criteria based on the type of service provider and guidelines established by law. The law also mandates the periodic evaluation of private health services and the publication of results to stimulate continuous advances in private healthcare.

Notably, the new law adds a provision to Law No. 9,782/1999:  Non-compliance with the strategy’s quality standards and qualification criteria may trigger a daily fine of BRL 5,000, which may be increased up to 100 times depending on the offender’s economic standing. The fine, however, does not absolve parties of civil liability for harm to patients, nor does it preclude other penalties arising from violations against health, consumer protection, and private health insurance regulations.

The strategy’s implementation will depend on regulations issued by ANVISA. The new law also stipulates that accreditation processes and other external assessments may be factored into the quality evaluation of healthcare facilities, without affecting other sector oversight frameworks, such as professional regulatory bodies.

COMPETITION LAW HIGHLIGHT IN THE HEALTHCARE SECTOR

A recent ruling concerning the distribution of pharmaceuticals and healthcare products also merits attention alongside these regulatory developments. This subject is particularly important for those assessing investments and corporate transactions in the Life Sciences and Healthcare sectors.

Brazil’s competition authority approves BTG’s acquisition of a stake in Viveo

The Brazilian Administrative Council for Economic Defense (CADE) unconditionally approved Banco BTG Pactual S.A.’s acquisition of a minority stake (less than 20%) in the capital stock of CM Hospitalar S.A. (Viveo), which operates in the distribution of medicines and healthcare products.

CADE reviewed a limited vertical relationship between:

• the Viveo group’s activities in the manufacture and distribution of disposable medical and hospital products, and the Pulsa group’s activities (in which the BTG Pactual Group holds a minority stake) in providing hemotherapy services (downstream); and
• the Viveo group’s activities in the distribution of medicines and medical and hospital products, and the Pulsa Group’s activities in providing hemotherapy services.

PUBLISHED REGULATORY ACTS

PUBLISHED REGULATORY ACTS

• LAW No. 15,524/2026 – Establishes the National Strategy for Quality Control and Assessment of Healthcare Services Provided by Private Healthcare Providers, providing for the definition of qualification standards, the periodic evaluation of healthcare providers, and the publication of the results.

MEDICINES

• ANVISA COLLEGIATE BOARD RESOLUTION (RDC) No. 1,042/2026 – Amends RDC No. 954/2024 to establish rules governing the transfer of ownership of marketing authorizations for clone medicines, specifically those approved under the criteria established in Collegiate Board Resolution (RDC) No. 31, dated May 29, 2014.
• ANVISA RDC No. 1,041/2026 – Amends Article 63 of Collegiate Board Resolution (RDC) No. 870, dated May 17, 2024, which governs the notification, marketing authorization, and post-authorization changes for medical gases classified as medicines.
• ANVISA NORMATIVE INSTRUCTION No. 469/2026 – Establishes a pilot project for the optimized quality assessment of marketing authorization applications for synthetic and semisynthetic medicines, based on the Structured Quality Summary (SQS).
• PUBLIC CALL NOTICE No. 06/2026 –  Public call for establishments holding an ANVISA Business Operating Authorization (Autorização de Funcionamento de Empresa – AFE) for the compounding of sterile preparations to voluntarily update their registration data and the activities they effectively perform, as well as to address any inconsistencies identified in the records kept by ANVISA.
• QUESTIONS AND ANSWERS REGARDING ANVISA RDC No. 742/2022 – A document issued by ANVISA providing guidance on the resolution, which establishes the criteria for conducting relative bioavailability/bioequivalence (BA/BE) studies and pharmacokinetic studies. The document seeks to clarify frequently asked questions on topics such as responsibility for procuring the reference/comparator drug, the participation of study subjects in BA/BE studies, and the administration of conventional-release and modified-release medicines.
• MANUALS AND GUIDELINES ON THE NATIONAL PRESCRIPTION CONTROL SYSTEM (SNCR) – Documents published by ANVISA to guide pharmacies, drugstores, and health oversight authorities on the new phase of the National Prescription Control System (SNCR), including expanded guidance tailored to the various stakeholders involved.

HERBAL MEDICINES

• BOOKLET AND INFORMATIONAL LEAFLET ON THE USE OF HERBAL MEDICINES – Updated by ANVISA, these materials supplement the publication of the regulations governing the marketing authorization of industrially manufactured herbal medicines, issued in December 2025.

ADMINISTRATIVE ENFORCEMENT PROCEEDING

• Q&A ON ADMINISTRATIVE APPEALS – ANVISA’s GGREC –  Originally published on September 21, 2020, and updated on September 15, 2026, this document clarifies the structure of ANVISA’s General Office of Appeals (GGREC), access to the grounds for decisions issued in administrative appeals reviewed by the General Office, the scheduling of oral arguments, the existence of ANVISA-specific rules governing the review of administrative appeals, and the authorities competent to rule on such appeals.

FOODS

• ANVISA NORMATIVE INSTRUCTION No. 470/2026 – Amends Normative Instruction No. 28, dated July 26, 2018, which establishes the lists of ingredients, use limits, claims, and additional labeling requirements for dietary supplements.

BEAUTY SERVICES

• TEMPORARY SUSPENSION OF THE TECHNICAL NOTE ON BEAUTY SERVICES – ANVISA has temporarily suspended the technical note while it reevaluates the guidelines. This suspension does not affect the validity of the health regulations applicable to the sector.

HEALTH OVERSIGHT

• MS-SVSA ORDINANCE No. 186  – Establishes, within the Secretariat for Health and Environmental Oversight, a working group to develop the Strategic Plan for the Implementation of the National Health Oversight Policy (PNVS) at the federal level.

PUBLIC PARTICIPATION

• PUBLIC CONSULTATION MS-ANVISA No. 1,420/26 – Proposed RDC on good practice requirements for the reprocessing of medical devices used in healthcare, among other provisions.
  Contribution deadline: January 28, 2027
• PUBLIC CONSULTATION MS-ANVISA No. 1,421/26 – Proposed RDC establishing good practice requirements for the reprocessing of medical devices in reprocessing companies that serve healthcare facilities, among other provisions.
  Contribution deadline: January 28, 2027
• PUBLIC CONSULTATION MS-ANVISA No. 1,422/26 – Proposed RDC establishing quality assurance guidelines for the development, validation, monitoring, and continuous control of protocols for the reprocessing of medical devices in healthcare facilities and in reprocessing companies that serve healthcare facilities, among other provisions.
  Contribution deadline: January 28, 2027
• PUBLIC CONSULTATION MS-ANVISA No. 1,423/26 – Proposed resolution establishing the classification and regulatory framework for single-use or reusable medical devices, among other provisions.
  Contribution deadline: January 28, 2027