2020 MDSAP Forum

2020 MDSAP Forum

From December 2nd to 4th, 2020, NCC participated in the 2020 MDSAP (Medical Device Single Audit Program) Forum, which took place virtually, with the presentation of the RAs (Regulatory Authorities) of each member country (Australia, Brazil, Canada, Japan, and USA). Also, on occasion, the AOs (Auditing Organizations) discussed essential topics on the approach to audits. About 60 participants attended these three days.

On the first day, essential topics were presented, including discussing and harmonizing remote auditing in times of COVID-19. This audit approach proposal can be used until 06/30/2021. The topics discussed were. Also, on the 1st day, new guidelines were presented on training MDSAP auditors and their modules, known as Articulate, which will only be available until the end of September/2021, when new training platforms will be made available.

On the 2nd day, the RAs made their presentations, with updates of information regarding the record and registration of medical devices in their countries, starting with TGA from Australia, Anvisa from Brazil, HC from Canada, MHLW and PMDA from Japan, and FDA from the United States. During Anvisa’s presentation for Brazil, it was informed that 55% of Good Manufacturing Practices (GMP) certificates were issued using the results of an MDSAP audit report. Also presented were updates within REPs, the system for recording information relating to MDSAP audits by AOs.

On the last day, before closing, the AOs stated their positions regarding the topics presented, proposing improvements in several aspects, mainly concerning the approach to remote audits in times of COVID-19.

NCC is a pioneer in Brazil in the MDSAP program, which can allow domestic or foreign manufacturers to market their medical equipment in member countries through the performance of a single audit.

Material subject to amendment(s) in case of change in the ordinance(s). Published: 12.09.20