Nov 30, 2016
EMERGO SUMMARY OF KEY POINTS:
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 3rd Edition series test reports, multiple audit reports from manufacturers and mandatory inspections of Brazilian Registration Holders (BRH).
Brazilian medical device market regulator ANVISA has published a new list of technical standards to which some electrical medical devices and IVDs must comply in order to obtain INMETRO certification in the country.
Safety certification for medical devices with electrical and other components has changed in Brazil.