​EMERGO SUMMARY OF KEY POINTS:

• ANVISA has delayed implementation of Ordinance 54/2016 on INMETRO certification for a second time.
• The new compliance deadline is set for April 29, 2017, but Brazilian regulators may delay implementation yet again.
• The new ordinance will introduce more challenging INMETRO certification requirements for medical devices that require such certification.

For a second time, Brazilian medical device regulators have extended a compliance deadline pertaining to INMETRO electronic safety certification for some manufacturers.

Compliance with Ordinance 54/2016, originally set to take effect August 1, 2016, was initially pushed back to December 31, 2016; now, INMETRO has extended the compliance deadline again to April 29, 2017.

In the meantime, according to Emergo consultants in Brasilia, manufacturers may continue to apply for INMETRO certification according to existing requirements under Ordinance 350/2010. Ordinance 54/2016 is considered more stringent than the previous ordinance, which helps explain ANVISA’s deadline extensions to allow companies more time to address compliance challenges.

Compliance to the new INMETRO ordinance will require substantially more documentation, as well as 60601 3^rd Edition series test reports, multiple audit reports from manufacturers and mandatory inspections of Brazilian Registration Holders (BRH).