Additional Certification
INMETRO Certification
The National Institute of Metrology, Standardization and Industrial Quality (INMETRO) mandates accredited Certification Bodies (OCP/CB) to conduct certification.
In February 2022, INMETRO launched its new regulatory framework which is more aligned with international best practices. The framework reduces the number of products under regulation, so that only products with a safety or environmental concern remain covered, allows for a greater use of self-declaration of suppliers and producers, when appropriate, as well as on the acceptance of international tests.
INMETRO certification is mandatory for all electro medical devices subject to IEC 60601, PPEs, needles, syringes, breast implants, condoms, and some other products.
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Minimum documentation required for initial INMETRO certification:
Quality
Manual
Packaging and Labelling
Risk
Management
Software Validation, when applicable
Usability Test
Report
Electric Schematics, when applicable
List of Critical Components
Diagram of Isolation, when applicable
Customer
Complaints
Tests performed overseas are usually accepted. So, instead of sending the medical device to Brazil, this option can help foreign companies save cost and time. After certification and approval by Anvisa, the medical device must bear an INMETRO label.
The INMETRO certificate doesn’t expire, but the manufacturer must undergo an annual maintenance inspection by the certification body.
ANATEL Certification
The Agência Nacional de Telecomunicações (ANATEL) certificate applies to medical devices that use radiofrequency (RF) spectrum or wireless communication, e.g. Bluetooth, Wi-Fi, etc.
For this certification, the device must be sent to Brazil for tests.
Steps for ANATEL Certification and Homologation:
Evaluate if Additional Certification is Required
We will determine whether any local certification requirements apply to your device, such as ANATEL or INMETRO certification.
Bridge the Gap
We will review the required documents and help you bridge any gaps for rapid and successful certification.
Network of Partners
We can connect you with our network of partners and specialists to expedite the certification processes.
...and much more!
Get in touch
Send us a message, we will be glad to help you through the pathway into the Brazilian market.
+55 (51) 3937-8726