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Under INMETRO Ordinance No. 54/2016

First active medical device project completed by TÜV SÜD Japan

Japanese experts from TÜV SÜD Japan, a member of one of the world’s leading technical service organizations, have completed their first project under INMETRO Ordinance No. 54/2016 governing medical devices. The organization issued an INMETRO certificate for active medical devices based on this INMETRO Ordinance on January 21, 2019. In the future, TÜV SÜD Japan will continue to support medical device manufacturers who need to transition to INMETRO Ordinance No. 54/2016 and medical device manufacturers who intend to sell medical devices in Brazil.

In February 2014, TÜV SÜD began providing full-scale INMETRO certification services to medical device manufacturers seeking to sell medical devices in Brazil. Based on TÜV SÜD’s extensive experience in projects under INMETRO Ordinance 350/2010 on medical electrical equipment, TÜV SÜD Japan began offering services in compliance with INMETRO Ordinance 54/2016 in 2018. The Japanese experts also played an important role in reviewing applications, factory inspections, and judging whether to award certification under INMETRO Ordinance No. 54. INMETRO inspectors witnessed these factory inspections with the customer’s cooperation and made judgments based on the results of conformity assessments.

Compliance with INMETRO Ordinance No. 54
In Brazil, medical device registrations are under the jurisdiction of the national health authority ANVISA (Agência Nacional de Vigilância Sanitária). Most electrical medical devices and some non-active medical devices require INMETRO certification to be registered with ANVISA. Compliance with the INMETRO Ordinance must be demonstrated in order to obtain INMETRO certification. INMETRO Ordinance No. 54/2016, which is currently in force, was issued on February 1, 2016. After April 30, 2017 evidence of compliance with this Ordinance must be provided. The certificates issued under former INMETRO Ordinance No. 350/2010 have a validity of 5 years. After their expiration, compliance to INMETRO Ordinance No. 54/2016 is mandatory. Therefore, transition to INMETRO Ordinance No. 54/2016 will be required to continue selling medical devices in Brazil.

TÜV SÜD INMETRO certification services
TÜV SÜD is accredited by INMETRO as a certification body for medical electrical equipment and provides certification services in accordance with INMETRO Ordinance No. 54/2016 for customers to obtain and maintain INMETRO certification. Customers can combine INMETRO Factory Inspections with audits according to other standards and directives, e.g. NRTL and ISO 13485. TÜV SÜD is also testing medical devices in accordance with INMETRO requirements.

As the critical processes of INMETRO certification are being overseen by Japanese experts, customers need not fear inadequate communication due to language barriers or time differences. Based on TÜV SÜD’s extensive experience in testing and registering medical devices and the organization’s in-depth knowledge of Brazilian laws and regulations, TÜV SÜD Japan will continue to provide comprehensive support for medical device manufacturers wishing to enter Brazil’s market.

For further information: https://www.tuvsud.com/en/industries/healthcare-and-medical-devices/medical-devices-and-ivd/medical-device-market-approval-and-certification/medical-device-registration-in-brazil

Press-contact: Dirk Moser-Delarami

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