Brazil Seeks Industry Feedback Following Manufacturing Inspections

Brazil’s medical device regulatory body—the Agência Nacional de Vigilância Sanitária (ANVISA)—currently is accepting industry feedback following Brazilian Good Manufacturing Practice (BGMP) inspections, the agency announced.

According to ANVISA’s website, medical device manufacturers now can 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 only will be used for investigational purposes, according to the 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 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 must acquire a BGMP certificate before being allowed to market in Brazil. The BGMP certification process, as Emergo noted, can be quite exhaustive.

Steps also have 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 United States.

The pilot program includes four IMDRF regulators including the U.S. Food and Drug Administration, 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.

Last fall, IMDRF 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.