Nov 22, 2019

A new report from Brazilian medical device market regulator ANVISA shows a significant increase in medical device manufacturers participating in the Medical Device Single Audit Program (MDSAP), with nearly half of all quality management system certifications issued in 2019 under MDSAP.

According to the ANVISA report (link in Portuguese), the number of device manufacturing sites in Brazil that participate in MDSAP totaled 5,002 in November 2019, up from 3,225 in 2017 and just 778 in 2017.

The number of Brazilian Good Manufacturing Practice (BGMP) quality system certificates issued under MDSAP parameters has also grown substantially in the past two years: from less than five percent of BGMP certificates issued in 2017 to nearly 49% of certifications in 2019.

Beyond Brazil: MDSAP adoption rates up worldwide

In a separate presentation ANVISA conducted in November, the regulator discussed distribution of MDSAP certifications approved outside of Latin America. The US accounts for nearly half of all MDSAP certifications, with Canada and Germany in distant second and third places.

In addition, the ANVISA presentation mentioned that European Union regulators are still in the process of developing guidelines for accepting MDSAP audit reports; Emergo by UL will continue monitoring these developments and report on MDSAP implementation details in Europe as they become available.

Learn more about Brazilian medical device regulations and MDSAP at Emergo by UL:

  • MDSAP internal and gap audit support
  • On-site MDSAP training for medical device manufacturers
  • Brazil ANVISA medical device registration and approval consulting
  • Whitepaper: Transitioning to MDSAP compliance