Anvisa takes part in the MDSAP 2026 Forum

Anvisa at MDSAP

From June 15th to 19th, the Brazilian Health Regulatory Agency (Anvisa) participated in the Medical Device Single Audit Program Forum (MDSAP) and the Regulatory Authority Council (RAC) meetings, which were held at the Kyoto International Conference Center in Japan.

The MDSAP 2026 Forum brought together international representatives from regulatory authorities, observers and affiliate members, as well as auditing bodies and representatives from the medical device industry. During the event, there was an active participation of countries from the Asia-Pacific (APAC) region and the Southeast Asian Network (SEARN), reflecting the growing global interest in the program.

The program included strategic topics such as cybersecurity requirements applied to medical devices, audition qualification, report improvement, and discussions on expanding and strengthening the MDSAP.

Some highlights included interactive sessions with the RAC and affiliated members, as well as panels dedicated to the perspectives and expectations of different regions, including APAC and SEARN. Practical experiences and lessons learned by affiliated members of the program, such as Argentina, Mexico, South Korea, South Africa, and Taiwan, were also shared.

Brazil had a strong relevance by presenting the theme "Medical Device Organizations Pilot," which led to an important discussion for the expansion of the program, reinforcing Anvisa's leading role in international technical and regulatory discussions.

In addition, the Agency took part in the updates of the Regulatory Authority Council, alongside other countries such as Australia, Canada, Japan, and the United States, sharing advances and strategic alignments of the program.

The program also included practical workshops focused on regulatory harmonization between different jurisdictions, as well as specific sessions for the exchange of experiences between regulatory authorities, audit bodies, and the industry.

About the MDSAP

The goal of the Medical Device Single Audit Programme is to allow healthcare product manufacturers to hire an audit institution, authorized under the program, to conduct a single audit that meets the requirements of the official regulatory authorities: Australia, Brazil, Canada, Japan, and the United States.