ANVISA announced its regulatory priorities for Medical Devices in 2020, that consist of the following:
• Working on regulations for the registration of software as a medical device (SaMD) in Brazil;
• Revisions to INMETRO Ordinance 54/16 as well as RDC 25/01 and RDC 156/06 pertaining to used and refurbished medical devices;
• Updates to the Normative Instruction on electromagnetic compliance certification;
• Launching a new product labeling and instructions for use uploading system to replace VisaDoc;
• Implementing a UDI system encompassing all of the Brazilian medical device sector.
Global Regulatory Partners Brazil, will keep posting updates on new ANVISA initiatives as they become available.
To learn more about Global Regulatory Partners, services in Brazil by checking the following:
• Brazil Registration Holder (BRH) in-country representation
• ANVISA Medical Device Classification
• ANVISA medical device regulatory strategy consulting
• ANVISA regulatory intelligence for Brazil Market
• ANVISA medical device registration and approval in Brazil consulting
• Brazil GMP (BGMP) quality management system compliance support