Brazil imports most of its medical devices, making it a lucrative market for foreign device manufacturers. Medical devices in Brazil are regulated by National Health Surveillance Agency (ANVISA) which grants the registration certificate for marketing. Medical devices with electrical components and some non-electric devices such as surgical gloves and condoms require additional certification issued by The National Institute of Metrology, Standardization and Industrial Quality (INMETRO) prior to initiation of ANVISA registration process.
Brazil’s Instituto Nacional de Metrologia, Normalização e Qualidade Industrial, also known as INMETRO, is the body responsible for recognizing certification organizations, which should be responsible for certification of products for compliance and authorization of approved certification marks. This certification scheme is known as the Brazilian Conformity Assessment System (SBAC).
To qualify for INMETRO certification, medical device manufacturers should get their products tested as per SBAC recognized standards by an INMETRO accredited testing laboratory.
Steps Involved in INMETRO certification:
- Document Analysis
- Pre-License Inspection
- Certification and Product Marking
At the end of a certification process, an applicant is authorized to use certification marks to demonstrate a device’s compliance. These marks are placed on both the approved medical device and on the product packaging.
INMETRO Certification Marks
INMETRO certification requires certain periodic activities after certification to continue its status as a certified manufacturer.
For an approved medical device, to stay INMETRO certified for the full five-year certification period, a manufacturer’s facility is subject to annual surveillance inspections. Appointing a local entity with sound knowledge on the requirements of INMETRO specifications & local certifiers is mandatory to simplify the process. In addition, INMETRO certification comes with many other significant unknowns.
Freyr has extensive experience with INMETRO certification in terms of requirements, communication, translation among other things. We can answer your queries and address any concerns you may have. Contact our experts at email@example.com.