Brazil’s National Health Surveillance Agency, Anvisa, has opened a targeted consultation on the Medical Device Single Audit Program (MDSAP) as part of its assessment of whether the programme should be expanded in Brazil.
The consultation is intended to increase participation from the regulated sector and collect information that will support an ongoing Regulatory Impact Assessment (RIA) evaluating possible alternatives for broader use of MDSAP in the country. Serviços e Informações do Brasil
Contributions are open until 9 November 2026, as also highlighted in Anvisa’s communication promoting the consultation.
Background to the MDSAP Discussion
According to Anvisa, a regulatory proposal presented at the end of 2025 considered making participation in MDSAP mandatory for medical device manufacturers.
Because of the potential impact of such a measure, the Agency initiated a Regulatory Impact Assessment to better understand the current situation, identify the regulatory problem and evaluate possible alternatives. Serviços e Informações do Brasil
The assessment is considering the potential:
benefits;
costs;
operational impacts;
regulatory impacts;
consequences for industry;
consequences for health surveillance.
Anvisa has not yet stated that mandatory MDSAP participation will be adopted.
The current consultation is intended to inform that decision-making process.
What Anvisa Wants to Understand
Anvisa is seeking practical information from companies regarding their experience with MDSAP.
The consultation specifically aims to collect information on:
companies’ experience participating in MDSAP;
barriers to joining the programme;
costs associated with participation;
potential positive impacts of broader MDSAP use;
potential negative impacts;
differences between companies already participating in MDSAP and those that have not yet joined. Serviços e Informações do Brasil
This information will be used to support the Agency’s Regulatory Impact Assessment.
Who Can Participate?
The consultation is directed at:
medical device manufacturers;
representative organisations from the regulated sector. Serviços e Informações do Brasil
Anvisa states that it has already conducted interviews with industry associations and medical device companies through its medical-device inspection and enforcement structures.
The new consultation represents an additional stage intended to broaden participation and collect evidence from a wider range of companies. Serviços e Informações do Brasil
Consultation Deadline
Interested stakeholders may submit their contributions until:
9 November 2026
Anvisa is collecting responses through an electronic questionnaire.
Access the Anvisa consultation questionnaire
What Is MDSAP?
The Medical Device Single Audit Program allows recognised auditing organisations to conduct a single regulatory audit of a medical device manufacturer’s quality management system that can address requirements from multiple participating regulatory authorities.
The programme is intended to improve regulatory cooperation and reduce duplication of inspections across participating jurisdictions.
For manufacturers active internationally, MDSAP can therefore form an important part of global quality-system and regulatory inspection strategies.
Consultation Is Not Yet a Regulatory Proposal
Anvisa makes an important distinction between this targeted consultation and a formal public consultation on a proposed regulation.
The current process is intended to collect data, experiences and evidence before the Agency decides which regulatory alternative should be pursued. Serviços e Informações do Brasil
This means that the consultation should not be interpreted as confirmation that MDSAP participation will become mandatory.
Instead, industry feedback will be used to evaluate the potential consequences of different options.
Potential Impact on Medical Device Manufacturers
Any broader use of MDSAP in Brazil could have significant implications for manufacturers.
Companies may need to consider issues including:
audit readiness;
quality management system maturity;
internal regulatory resources;
costs associated with MDSAP certification;
relationships with recognised auditing organisations;
inspection planning;
global market strategy.
For organisations that already participate in MDSAP, the impact may be different from that experienced by smaller manufacturers or companies operating primarily in Brazil.
This is one of the reasons Anvisa is seeking feedback from organisations with different levels of experience with the programme.
Why Industry Participation Matters
Anvisa states that industry contributions will help it better understand the diversity of the medical device sector and assess the consequences of the alternatives being considered.
The consultation provides manufacturers and representative organisations with an opportunity to provide evidence on the practical, financial and operational impact of any future expansion of MDSAP in Brazil. Serviços e Informações do Brasil
For regulatory and quality teams, this is therefore an important opportunity to contribute directly to the Agency’s assessment before a final regulatory approach is defined.
Next Steps
Following the consultation, Anvisa will continue its Regulatory Impact Assessment and evaluate the information received together with evidence gathered through previous stakeholder interviews.
The outcome may inform future regulatory proposals concerning the role of MDSAP in Brazil.
At this stage, stakeholders should focus on providing concrete evidence regarding implementation challenges, costs, benefits and operational impacts.
