Brazil - Draft Update on Regulation for Mandatory Certification of Medical Devices
Business description
The Inmetro Decree 259 of May 27th 2019 is a draft version open for public consultation for 60 days to change requirements related to the conformity assessment requirements of Medical Devices according to Inmetro Decree 54/2016.
The main updates refer to the obligation of the certification body to inform Inmetro and Anvisa about product changes in the certified products. Another requirement refer to the identical products produced in different factories will have to be declared in separate certificates (1 certificate per factory).
Countries:
Brazil
Technical aspects:
EMC
Safety
Business fields:
P.05 Medical
Regions:
South-America
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