By Stewart Eisenhart, Emergo Group
During the annual Hospitalar medical device and technology conference in Sao Paolo, Emergo Group learned that Brazilian medical device market regulator ANVISA plans to launch a two-year trial period to allow third-party audits of Brazilian Good Manufacturing Practice (B-GMP) quality systems.
ANVISA has set a tentative start date of January 2014 for the trial; the US, Canada, Brazil and Australia are expected to participate, meaning that third-party certifiers would be able to audit a manufacturer’s quality system for US, Canadian, Brazilian and Australian requirements at the same time.
Although third-party inspectors will be able to perform B-GMP audits, they will not issue B-GMP certificates. The inspectors will instead provide reports to ANVISA, and the regulator will then issue final certification to the manufacturer in question.
ANVISA and other regulators will hash out further details on the program at an International Medical Device Regulators Forum (IMDRF) Working Group meeting in July in Tokyo, followed by submission of finalized documents for approval in November.
(This auditing program is intended to be an additional option for companies that require B-GMP quality management system inspections; the “normal” process of requesting and receiving inspections directly from ANVISA will continue to be available.)
Emergo Group will be monitoring ANVISA and the IMDRF Working Group for further developments.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.
