Exporting Medical Devices to Brazil: Seven Step Process (Part 4)

26 Sep 2011

Over the last few weeks, this blog has explored how manufacturers can ensure that their medical devices are ready for the Brazilian market. As part of this four-part blog series, today's discussion provides a brief snapshot of what every medical device equipment manufacturer should know and prepare for when in order to export to Brazil.

• Mandatory Certification: Mandatory certification is required for insulated wires & cables to 750V, electro-medical equipment, hazardous location equipment, equipment for gas system, electrical cord and cable, protection device (circuit breaker, fuse, etc.) switches, voltage stabilizers, plug and socket and household equipment are now mandatory (as of July 2011.)
• Certification bodies: These must be accredited by INMETRO (National Institute of Metrology, Quality and Technology)
• Safety standards:
  • Brazil National Standards (ABNT) are primarily IEC-based standards.
  • AC supply voltage is 110-127 V, 60 Hz and 220V, 60 HZ, depending on location
  • Power supply cords must meet specific requirements for conformity assessment.

To learn more about this subject and to speak with Intertek expert that can help your device become ready to export to Brazil, e-mail us at askmedical@intertek.com or visit https://www.intertek.com/medical/.