Recently ANVISA has published two regulations RDC 340/2020 and IN 61/2020, introducing from April 1, 2020 new classification rules for medical device changes. The changes to the device have been classified in three categories, based on the change type and the risk for health.
- Changes to be pre-approved are the highest-level impact changes for health and are authorized after ANVISA approval only.
- Changes with Immediate implementation, that are the medium-level impact changes for health and are authorized after ANVISA submission only. ANVISA executes periodical inspections to assess the changed devices is in compliance;
- Changes not to be reported, that are the lowest-level impact changes for health and can be implemented without informing ANVISA.
All changes to medical devices must be managed in compliance with the Brazilian Good Manufacturing Practice (BGMP) ref. RDC 16/2013.
The regulations have been developed according to the suggestions of manufacturer and importer associations of medical devices operating in Brazil, such as:
- Brazilian Association of High Technology Healthcare Products Industry (Abimed)
- Brazilian Association of the Medical, Dental, Hospital and Equipment Industry (Abimo)
- Brazilian Association of Importers and Distributors of Healthcare Products (Abraidi)
- Brazilian Laboratory Diagnosis Chamber (CBDL)