Regulatory updates in Brazil you should know about

By Stewart Eisenhart, Emergo Group

While Brazil’s political scene has taken a turn for the dramatic in recent weeks, the country’s medical device sector has seen its own share of excitement over steep registration fee increases (and reversals), MDSAP participation and related issues.

Brazilian medical device market news over the past several months includes:

• A successful lawsuit against the government will allow some manufacturers to pay reduced ANVISA registration and Brazilian Good Manufacturing Practice (BGMP) inspection fees sooner

• Brazil’s telecommunications regulator ANATEL has updated labeling rules for wireless products that include some medical devices
• INMETRO certification requirements for some electrical medical devices have been aligned with IEC 60601 3^rd Edition
• Two Medical Device Single Auditor Program (MDSAP) auditors have been officially recognized by ANVISA: TÜV SÜD America and BSI Group
• According to an Emergo analysis of ANVISA data, the regulator has improved timeframes for handling medical device registration submissions during 2015
• After actions by the Brazilian Ministry of Finance signaled a major increase in ANVISA registration and BGMP inspection fees autumn 2015, the Brazilian legislature moved in late 2015 to limit those increases, heading off a potentially prohibitive market entry cost for many foreign manufacturers

More information on Brazilian medical device regulations is available via Emergo’svideo overview of the ANVISA approval process, white paper on BGMP compliance and regulatory process chart on ANVISA registration.

Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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