New INMETRO, IEC 60601 Requirements in Brazil

Brazilian regulators have issued new requirements under Normative Instruction 9/2013 that expand certification requirements for some electronic and other medical devices.

First, IN 9/2013 adds 30 types of medical devices to the list of products requiring INMETRO certification in order to obtain market authorization in Brazil. Devices that now require INMETRO certification include self-test glucose meters, products where 61010-2-101:2002 testing is applied, gas mixers used for medical purposes and in vitro diagnostic (IVD) equipment.

Second, compliance with the 3rd edition of the NBR IEC 60601 standard for electrical equipment is now required for INMETRO certification. However, ANVISA will on a temporary basis accept INMETRO certifications using IEC 60601 2nd Edition that were obtained after December 31, 2013, but only until the full accreditation and training of the medical device applicant’s INMETRO certifier.

According to our industry and regulatory sources in Brazil, no INMETRO certifiers have the capability currently to issue test reports according to the new IEC 60601 standard. Until INMETRO laboratories are able to certify devices according to IEC 60601 3rd Edition, registrants will need to submit letters from their INMETRO certifiers explaining inabilities to provide test results based on the new standard.

ANVISA has set a December 2014 deadline for implementing new regulations requiring all INMETRO certifiers be accredited and trained in IEN 60601 3rd Edition. For the time being, existing INMETRO certification requirements remain in effect for medical device registrants.

Emergo Group believes ANVISA will provide official notice that IEC 60601 2nd Edition-compliant INMETRO certification will continue to be accepted on a temporary basis, but the regulator has issued no such statement as of yet. We continue to monitor the developments around IN 9/2013 and will provide additional details as soon as possible.

Stewart Eisenhart

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