RDC 591/2021
Marcelo Brisolla
CEO I Senior Executive I Legal Expert | Regulatory Affairs I Healthcare I Medical Devices I Environmental Health Consultant I BPO in RA I Services I ANVISA
Today there was a meeting of the Collegiate Director Board of ANVISA and the proposal to modify RDC 591/2021 (regarding the UDI system) was voted. The proposal was approved unanimously and must be published in the Official Gazette in the coming days.
Among the approved proposals are:
1) Exclusion in the RDC 591/2021 of articles with the word “facultado”, such as paragraph 1 of article 8.
2) Exclusion of the specific UDI requirement for reprocessed products.
3) Change of the expression: "Produtos para a Saúde" to "Dispositivos Médicos", it means "Health Products" to "Medical Devices".
4) New proposed deadlines for the implementation of RDC 591/2021:
- 3.5 years for risk class IV products (july 10, 2025)
- 4 years for risk class III products (january 10, 2026)
- 5 years for risk class II products (january 10, 2027)
- 6 years for risk class I products (january 10, 2028) - unchanged.
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