Key Takeaways from the 5th International Medical Devices Seminar in São Paulo/Brazil

This blog was originally posted on 3rd September, 2025. Further regulatory developments may have occurred after publication. To keep up-to-date with the latest compliance news, sign up to our newsletter.

AUTHORED BY FERNANDA PARO, SENIOR REGULATORY COMPLIANCE SPECIALIST, COMPLIANCE & RISKS

I recently attended the 5th International Medical Devices Seminar, held on 27-28 August in São Paulo, which brought together regulators, industry representatives, and experts to discuss key developments in the medical device regulatory landscape. The event highlighted Brazil’s strategic role in shaping global discussions, particularly through its active participation in the International Medical Device Regulators Forum (IMDRF) and the Medical Device Single Audit Program (MDSAP).

Below I highlight the key trends from the conference.

Industry’s Role in the Regulatory Context

One of the central themes at the seminar was the role of industry in the regulatory environment, especially in relation to IMDRF, MDSAP, and ANVISA.

Brazil continues to play a significant role within the IMDRF, holding seats on the management committee and in working groups focused on Quality Management Systems, Software as a Medical Device, and Personalized Medical Devices.

Current Priorities Under Discussion

At the Forum, current priorities under discussion included:

• Reliance, which is gaining traction and expanding in Brazil, aims to optimize resources, avoid duplication, and speed up access to safe and effective medical devices.
• Regulatory convergence, which refers to the gradual alignment of requirements and practices across jurisdictions. The aim is not identical regulations, but reducing unnecessary differences, streamlining compliance, and improving efficiency. This often involves adopting international standards (e.g. ISO 13485) or harmonizing definitions and documentation, ultimately helping manufacturers avoid duplication and improving patient access to medical devices in multiple markets.
• ISO 13485 revision (currently deprioritized in favor of other pressing issues).
• Post-market challenges and solutions Key challenges include adverse event reporting, surveillance of real-world performance, and managing recalls or corrective actions. Solutions involve strengthening post-market surveillance systems, data sharing among regulators, and enhanced collaboration with manufacturers to quickly identify and mitigate risks.

Updates on the MDSAP

Another key point addressed was the MDSAP, a global program that enables medical device manufacturers to undergo a single audit recognized by multiple regulatory authorities: Brazil, Australia, Canada, Japan, and the United States.

Applications for recognition as an MDSAP Auditing Organization (AO) officially reopened on 1 July 2025. Companies that are part of MDSAP undergo an audit every year and, as a result, gain greater credibility in the market. This yearly audit structure provides not only compliance assurance but also a strong signal of quality to the market.

Benefits of MDSAP for Manufacturers

The benefits of MDSAP for manufacturers include:

• More efficient use of resources;
• Evaluation of quality systems against ISO 13485 and specific national regulations;
• International recognition of a standardized quality framework;
• Use of audit results to support market entry in participating jurisdictions;
• Greater efficiency in Good Manufacturing Practices (GMP) certification processes.
  

What are the Latest Regulatory Developments?

The latest MDSAP update, published on 28 July 2025 (effective on 1 August 2025), extended the eligibility to participate in the program. This change allows certain types of Medical Device Organizations (MDOs), those subject to QMS or GMP requirements in participating jurisdictions but not marketing devices under their own name or brand, to join MDSAP.

As a result, most organizations involved in the design and manufacture of medical devices, and subject to regulatory quality system requirements, are now eligible. To qualify, these organizations must meet at least one of the criteria outlined in Item 5.1 of the updated guidance.

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Looking Ahead: Brazil’s Leadership in Global Regulation

It is also noteworthy that Brazil will assume the presidency of the IMDRF in 2027 and of the MDSAP in 2028/2029. This upcoming leadership role reflects Brazil’s growing influence and commitment to advancing global medical device regulation.

By strengthening its presence in international forums, Brazil not only contributes to shaping harmonized standards but also enhances its position as a key hub for medical device innovation and compliance.

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