Brazil’s medical device market expanded at double-digit rates through 2011-2013, and is expected to continue this rate as 2014 turns into 2015. About 80% of medical products in Brazil are imported. As a member of the IMDRF, and as a nation included in the Medical Device Single Audit Program (MDSAP), Brazil has made strides to open wider its medical device market to the rest of the world.
INMETRO, the National Institute of Metrology, Standardization, and Industrial Quality of Brazil, is an integral part of the medical device regulatory registration in Brazil. Its role as an accreditation body and standardization organization puts it at an important intersection between industry and ANVISA, the Brazilian medical device regulator. INMETRO certification is a requirement for electromedical device manufacturers who wish to market their devices in Brazil, and is an additional and required step in their regulatory submission to ANVISA.
What is INMETRO and what is its role in medical device certification?
INMETRO implements and executes the metrology and quality policies that are promulgated by CONMETRO, the National Council of Metrology, Standardization, and Industrial Quality. CONMETRO and INMETRO were created in 1973 to support the Brazilian internal market and increase their productivity and the quality of their goods and services.1 Some of INMETRO’s duties include technical support to CONMETRO and other agencies in the Brazilian government, developing standards and conformity assessment programs, and accrediting certification bodies. INMETRO also develops Brazil’s legal metrology programs and guidelines.
As a standards organization, INMETRO also develops and adopts the standards for electrical appliances, including electromedical devices. INMETRO certification is a requirement not only for electromedical devices, but a wide range of products like televisions and automobiles.
Electromedical devices, regardless of their class, must have a certificate from INMETRO to certify that they work safely.2 These devices can be certified by a third-party certification body that INMETRO accredits through CGRE, INMETRO’s certification agency. As a result of this accreditation, certification bodies can certify that the device in question meets INMETRO’s standards, which are equivalent to IEC 60601-1, IEC 60601-2, and ISO 13485.3 INMETRO certification is valid for 5 years after the date it was issued, and may be renewed for an additional 5 years. Within the process of registration for an electromedical product in Brazil, the INMETRO certification comes before the ANVISA approval, as the INMETRO certificates are part of the medical device’s technical documentation that must be submitted to ANVISA.
How does an electromedical device manufacturer receive INMETRO certification?
To receive INMETRO certification for an electromedical device, the manufacturer must test the product in an INMETRO-certified testing laboratory. Usually, this process is in three broad steps:
The certification body and testing laboratory could conduct a small feasibility study using the information about the manufacturer, the device from the manufacturer, and documents about the device like user manuals, packaging samples, and, if applicable, another testing lab that is internationally accredited.
The certification body and testing lab analyze the documents to validate the tests done on the device.
Finally, an on-site audit is conducted to verify that the manufacturer’s quality management system conforms to the INMETRO standards.4
It is important to note that for electromedical devices, a manufacturer must conform not only to ANVISA regulations but also INMETRO standards as a result of the testing and quality management system audit. However, some certification bodies may be able to combine the INMETRO quality management system audit with other audits to save the manufacturer time and money. Further, some testing laboratories may be able to test an electromedical device to multiple standards. These combined audits and tests work together to save a manufacturer time and money.
For more information about how LNE/G-MED can help guide an electromedical device manufacturer to register their devices in Brazil, please do not hesitate to contact us.
2 RDC 27/2011.
3 Portaria INMETRO 350.