Australia’s TGA Medical Device Reform to reclassify certain medical devices
TGA has decided to reform their medical device classification due to safety issues identified and to further harmonize to the European Union.
ANVISA NEW REGULATION FOR POST-APPROVAL CHANGES TO MEDICAL DEVICES: RDC 340/2020
On March 3, 2020, Anvisa published a new regulation “RDC 340/2020” that classifies the changes made to approved medical devices in Brazil, into three categories based on the level of risk .