IEC 60601 is the international standard for safety of electro-medical devices. Electro-medical devices entering Brazil require a mandatory INMETRO* IEC 60601 product certification, this must be completed before applying for ANVISA registration. BSI Brazil is accredited by INMETRO to issue IEC 60601 Product Certification.
All electro-medical manufacturers must have a local representative that will apply for product certification. Medical devices must be tested to IEC 60601 and the relevant parts of the standard, manufacturers will audited by the INMETRO Product Certification Body or their approved agent, product certification is issued for up to five years.
* INMETRO is the national accreditation body for testing, certification and system assessment.