The prospect of a standardized single audit program for medical devices, currently being developed by the International Medical Device Regulators Forum, is fueling efforts by Brazil’s Anvisa to bring device good manufacturing practice regulations in line with international standards, an expert says.
The effort is tied to Brazil’s push to become an international destination for device manufacturing with streamlined GMPs and harmonized standards that will enable it to compete on a global scale.
“One of [Anvisa’s] main areas of concern is … to correct a problem they created in the past regarding international GMP inspections,” said Marcelo Antunes, regulatory affairs strategy consultant with SQR Consulting in São Paulo. According to Antunes, the agency lacks the required staff to perform those inspections and is currently anywhere from two to four years behind schedule.
To that end, Anvisa is developing a regulation on conditions for granting certificates of good manufacturing practice, good distribution practice and storage. Companies that make both devices and in vitro diagnostic devices will need separate GMP certification for each type of manufacturing process.
Antunes expects the regulation, which went through a public consultation earlier this year, to result in better GMP application throughout the industry and easier compliance during inspections. The regulation “will make the process more streamlined, although not necessarily cheaper,” he said. Anvisa expects to publish a final regulation in the near future, following a review of stakeholder comments.
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