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Brazil: May 1 Compliance Deadline Stands for New INMETRO Certification Requirements

EMERGO SUMMARY OF KEY POINTS:

  • May 1, 2017 remains the official deadline for compliance with Brazilian INMETRO Ordinance 54/2016.
  • The new INMETRO ordinance contains stricter certification requirements and higher compliance costs.
  • INMETRO proposals signed by April 30, 2017 will still qualify for certification under previous requirements.

INMETRO Ordinance 54/2016 for medical device companies in BrazilBrazilian regulators are leaving in place the latest deadline of May 1, 2017 for new INMETRO certification requirements for some medical devices, despite extending this deadline twice in the past.

As first reported by Emergo in early 2016, the new INMETRO Ordinance 54/2016 is based on IEC 60601 3rd Edition safety and performance standard for electronic medical equipment. The Ordinance entails stricter requirements including onsite on-site audits of device importers, lengthier on-site audits of manufacturers and stronger risk management rules.

Longer INMETRO certification timeframes

Based on communications between Emergo consultants in Brasilia, INMETRO certifiers and Brazilian industry trade group ABIMED, regulators do not plan to extend Ordinance 54/2016’s effective date a third time.

INMETRO certifiers have advised Emergo sources, however, that they are not yet prepared to certify devices according to the new Ordinance.  This will likely result in longer timeframes for INMETRO certifiers to issue new proposals.

What about INMETRO applications already under review?

In terms of which manufacturers will fall under INMETRO Ordinance 54/2016, any INMETRO proposal signed by April 30, 2017 will fall under the old requirements (Ordinance 350/2010); INMETRO certification for any such proposal must be completed by April 30, 2018.

INMETRO certificates issued under Ordinance 350/2010 will remain valid for five years, after which time manufacturers will have to re-certify under Ordinance 54/2016.

More about INMETRO and Brazilian medical device registration:

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