Brazil's ANVISA Opens Targeted Consultation on Whether MDSAP Should Become Mandatory: Comments Due 9 November 2026

ANVISA Opens Targeted Consultation on Expanding MDSAP in Brazil

On 21 October 2026, Brazil's National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA) published a targeted consultation on its website titled Anvisa amplia participação do setor em discussão sobre o MDSAP ("ANVISA broadens industry participation in the MDSAP discussion"). The consultation seeks input on options for expanding the use of the Medical Device Single Audit Program (MDSAP) in Brazil and is intended to support the agency's Regulatory Impact Analysis (Análise de Impacto Regulatório, AIR). The deadline for participation is 9 November 2026. At this stage, no registration requirement in Brazil has changed: MDSAP participation remains voluntary.

Background: Why the Consultation Has Been Opened

The announcement sets out the background. In late 2025, a regulatory amendment proposal was put forward that would have made participation in MDSAP mandatory for medical device manufacturers. In view of the potential impact of such a measure, ANVISA initiated a Regulatory Impact Analysis to map the current situation, identify the regulatory problem, and compare possible options against their benefits, costs, and effects on industry and on the health surveillance system.

In other words, what is currently on the table is an assessment process that has not yet been concluded. The process has not reached the stage of a draft regulation. Whether the outcome will be mandatory participation, continued voluntary participation, or an intermediate approach has not been decided.

Who May Participate and How to Submit

The announcement states that the targeted consultation is directed at medical device manufacturers and representative bodies of the regulated industry. Participants submit their input through an electronic form hosted on the FGV platform at https://survey.fgv.br/jfe/form/SV_89exdUCZ0w5J6po, with a deadline of 9 November 2026.

The announcement also clarifies that the targeted consultation takes place before regulatory options are defined and is intended to collect data and empirical evidence. It is a social participation mechanism within the AIR process, whereas a public consultation is the mechanism through which interested parties comment on specific draft provisions. This distinction is important: submissions at this stage should focus primarily on verifiable cost data and experience-based evidence, rather than on statements of principle.

Work Already Completed

The announcement also indicates that this work did not start from zero. The unit responsible is the Health Products Inspection and Monitoring Management (GIPRO), within ANVISA's health surveillance structure. ANVISA has already conducted interviews with industry associations and with a number of medical device companies. The new phase has been opened to broaden the range of stakeholders heard and to allow more companies to participate directly in shaping the AIR.

The announcement specifically states that ANVISA wishes to understand:

• companies' practical experience in dealing with MDSAP;
• the difficulties encountered in joining the program;
• the costs involved;
• the potential positive and negative effects of expanding use of the program in Brazil.

ANVISA emphasises that the circumstances of both companies already participating in the program and companies that have not yet joined should be taken into account.

Participants and Non-Participants Are Not Being Asked the Same Questions

Judging from the questions listed in the announcement, the two groups of companies can provide different types of information.

Facilities that have already completed an MDSAP audit hold first-hand data on audit days, the distribution of nonconformities, the actual savings achieved through mutual recognition of reports across participating regulators, and the time saved when using the simplified pathway in Brazil. This is precisely the type of data that the AIR most lacks.

Companies that have not yet joined can articulate where the barriers lie: whether it is more expensive to conduct a full additional audit for a single production line or to consolidate audits across five countries into one cycle; whether the greater difficulty lies in redesigning the documentation system or in securing an audit slot.

ANVISA has explicitly stated that both categories of companies fall within the scope of the consultation. This means that companies that have not yet joined also have a role to play and should not assume that, without an MDSAP certificate, they have nothing to submit.

No Rules Have Changed at This Stage

It is important to distinguish between consultation and rule-making. As of the verification date for this article, Brazil has not changed its registration requirements as a result of this consultation. MDSAP participation in Brazil remains voluntary. The targeted consultation itself has no legal effect and does not constitute a change to the registration conditions for any specific product.

Actual rule changes will only emerge after the AIR has been completed, ANVISA has selected a preferred option, and the relevant normative instruments have gone through the required procedure.

Accordingly, reading this consultation as meaning that MDSAP is already mandatory, or suspending registration plans in Brazil on that basis, would be an overreaction. Conversely, treating it as an unrelated procedural step and ignoring it entirely would mean missing an opportunity to contribute at the lowest possible cost.

The Window Is Less Than Three Weeks

From publication on 21 October 2026 to the 9 November 2026 deadline, companies have less than three weeks to compile their materials. Given that internal data such as audit quotations, audit-day records, travel costs, and production downtime losses must be retrieved, the time realistically available for preparation is even shorter.

For companies filing in multiple markets, this window also overlaps with audit scheduling in the United States, Canada, and Australia. The later a company starts, the more likely it is that only statements of principle can be submitted.

AIMEILI Regulatory Interpretation

The consultation should be understood as an evidence-gathering step within ANVISA's Regulatory Impact Analysis, not as a prelude to an already-decided mandate. ANVISA has deliberately separated the AIR phase — which collects data on difficulties, costs, and impacts — from the later public consultation phase, in which specific draft provisions would be commented on. Companies that treat the two phases as interchangeable risk submitting position statements that carry little weight in the current exercise.

Two features of the announcement are particularly relevant for regulatory strategy. First, ANVISA explicitly invites input from manufacturers that have not yet joined MDSAP. This signals that the agency is testing whether the barriers to participation are structural — cost, audit capacity, documentation redesign — rather than assuming that non-participation reflects a lack of interest. Second, the reference to the GIPRO-led interviews already conducted with associations and companies indicates that the AIR is being built on a defined evidence base; submissions that supply comparable, quantified data are more likely to be reflected in the option selected.

It should also be noted that the consultation has no legal force and does not modify any registration pathway. MDSAP remains voluntary in Brazil, and the applicable requirements, audit arrangements, and registration routes continue to be governed by ANVISA's official texts and any subsequent formal instruments.

Business Impact

• No immediate change to registration planning. Companies with Brazilian registration projects should continue on their current pathway. MDSAP is not mandatory, and the consultation does not alter the conditions for any product registration.
• A low-cost opportunity to shape the outcome. Companies that already hold MDSAP certificates can supply audit-day, nonconformity, and cost data that are directly usable in the AIR. Companies without MDSAP can document the specific barriers and cost drivers they face. Both types of input are within scope.
• Regulatory intelligence value. A future decision to make MDSAP mandatory would affect audit budgets, notified body capacity planning, and multi-country audit scheduling. Companies that participate in the consultation gain earlier visibility into the direction of travel.
• Resource planning. With less than three weeks between publication and the deadline, and with overlapping audit schedules in the US, Canada, and Australia, internal data collection should begin immediately if a substantive submission is intended.
• Group-level coordination. For multinational manufacturers, submissions are best coordinated centrally so that affiliate-level experience, global audit costs, and site-specific barriers are presented consistently.

Source and Scope Notes

Source: Agência Nacional de Vigilância Sanitária (ANVISA), Brazil, news item Anvisa amplia participação do setor em discussão sobre o MDSAP, published 21 October 2026. The participation form address given in the announcement is https://survey.fgv.br/jfe/form/SV_89exdUCZ0w5J6po, and the announcement page is available at https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/anvisa-amplia-participacao-do-setor-em-discussao-sobre-o-mdsap.

Verification scope and access date: The full text of the ANVISA announcement page was accessed and read on 31 October 2026, and the publication date, deadline, target audience, submission channel, and AIR background statements were checked. Descriptions in this article concerning the scope of regulators participating in MDSAP are public background information and were not restated in this announcement. Details not disclosed in the announcement — such as the specific list of AIR options and the final timetable — are not speculated upon here.

Scope note: This article is an interpretation of publicly available regulatory information and does not constitute a conclusion or commitment regarding any specific product, company, or registration application. The applicable MDSAP requirements in Brazil, audit arrangements, and registration pathways are governed by ANVISA's official texts and subsequent formal documents, and the relevant information may change as official updates are issued.

Information Source

Agência Nacional de Vigilância Sanitária (ANVISA), Brazil — 21 October 2026.