News Feature | November 20, 2014

Brazil's ANVISA Seeking Industry Feedback Following Manufacturing Inspections

By Nick Otto


Brazil’s medical device regulatory body, the Agência Nacional de Vigilância Sanitária (ANVISA), recently announced that it will now be accepting industry feedback following Brazilian Good Manufacturing Practice (BGMP) inspections.

According to an announcement on the agency’s website, medical device makers now have the chance to submit a form to the regulator after an inspection, allowing companies to provide feedback on how the inspection went and to recommend any improvements that could be made to the process.

The evaluation will only be used for investigational purposes for now, according to the medical device consulting firm Emergo Group, which added that it does “show perhaps willingness by Brazilian regulators to take more industry feedback into consideration during the BGMP inspection process over the longer term.”

According to ANVISA, the process was organized by the General Office of Health Inspection with sights set on improving the inspection process and ensuring the standardization of inspections.

ANVISA noted that in order to improve the inspection process, it is vital to incorporate the feedback from the inspected companies. The evaluation will be conducted through a questionnaire that must be completed by a representative of the inspected firm or company.

Device makers are required to acquire a BGMP certificate before being allowed to market in the country. The BGMP certification process, as Emergo added, can be a very lengthy process.

Steps have also been taken to further develop the use of the Medical Device Single Audit Program (MDSAP) pilot, which is supported by the International Medical Device Regulators Forum (IMDRF). The IMDRF is a group of medical device regulators that includes ANVISA and other regulatory bodies from Australia, Brazil, Canada, and the U.S.

The pilot is set to launch in January and will include four IMDRF regulators including the FDA, ANVISA, Health Canada, and Australia’s Therapeutic Goods Administration. Other IMDRF agencies are in support of the initiative and some, including both Japan’s Ministry of Health, Labour, and Welfare, and the Pharmaceuticals and Medical Devices Agency, will sit in as observers during the pilot program.

IMDRF earlier this fall issued a final document explaining how third-party auditing organizations will be approved, including the grading of nonconformities. It added that Brazil’s regulatory authority, ANVISA, will take over the MDSAP chairmanship in 2015.