Brazil ANVISA Announces Priorities for the 2026-2027 Year

By Luiz Levy, Priscila Sanada and Evangeline Loh

Background on ANVISA Regulatory Agenda

The medical device market regulator in Brazil, ANVISA, announced its priorities “Regulatory Agenda” for the 2026-2027 Year (Ordinance No. 1.484/2025, published December 16, 2025, in effect January 1, 2026).  

Similar to the 2024-2025 priorities, this document is approved by ANVISA and then formally published in the Federal Official Gazette and consists of topics from the previous agenda as well as topics in specific areas, including medical devices.

Background on 2026-2027 ANVISA Regulatory Agenda

The most recent Regulatory Agenda (Ordinance No. 1.484/2025) is divided into 16 sections, including a total of 161 topics, of which 97 topics are from the 2024-2025 priority list. 

There are 38 new topics, and 14 topics identified for medical devices (section 5). 

Priority general topics that may be of interest

A highlight of some general topics that may be of interest to medical device manufacturers:

• Authorization for depletion of stock of products subject to sanitary surveillance. This is of interest as the stock depletion timeframe varies across products.
• Procedures for classifying borderline products.
• Procedures related to the analysis and decision-making of administrative appeals submitted to the General Management of Appeals.
• Regulation defining procedures related to ANVISA’s inspection activities.
• Requirements for the regularization of products intended for aesthetic procedures with dermal action.
• Revision of criteria and procedures to enable the supply of products subject to sanitary surveillance by the Unified Health System, which is proposed to anticipate and effectively respond to health crises and public health emergencies.
• Targeted revision of the transfer of ownership of regularized products, proposed revision of Resolution RDC No. 903/2024.
• Validity of the Good Manufacturing Practices Certificate (CBPF), at present, product registration remains valid for 10 years, whereas for medical devices, the BGMP certificate is valid for only 2 to 4 years. As a result, manufacturers of medical devices have advocated for a longer BGMP validity period.
• 1.17 Revision of Importation regulation, proposed revision of RDC 81/2008.

List of the 14 medical device topics

The 14 medical device topics are as follows: 

• Update of the regulatory framework for tattoo pigments.
• Sanitary control of combination products.
• Release of the ANVISA Unique Device Identification (UDI) database (SIUD), as required by §3 of Article 15 of RDC No. 591/2021. Emergo hosted a webinar and reported on this previously.
• Identification of strategies to promote access to information necessary for the safe use of medical devices by people with visual impairments.
• Economic monitoring of medical devices.
• Mandatory participation in MDSAP for certification of international medical device manufacturers, proposed revision of RDC No. 687/2022.
• Regulation of novel medical devices.
• Regulation of in vitro diagnostic (IVD) medical devices subject to prior review.
• Reprocessing of medical devices, a topic that appears to continually be on the priority agenda.
• Requirements for prior review of self-testing systems for blood glucose monitoring (glucometers, test strips, controls, and calibrators).
• Revision of the regulation of software as a medical device (SaMD), proposed Revision of RDC No. 657/2022.
• Revision of the regulatory framework for vigilance, focusing on companies holding registrations for medical devices.
• Revision and update of the standard governing the registration of personalized medical devices.
• Periodic update of certification for equipment under sanitary surveillance within the scope of the Brazilian Conformity Assessment System (SBAC).

Concluding remarks

This list is exciting and formidable. Emergo has a large consulting practice in Brazil and will continue to monitor and report on these regulatory developments. 

And, while all of these priorities are interesting, we’re most fascinated by the proposed requirement for manufacturers not based in Brazil to possess an MDSAP certificate.