MERCOSUL Regulatory Roadmap
ANVISA and its MERCOSUL counterparts (ANMAT in Argentina, MSP in Uruguay, DINAVISA in Paraguay) are working towards greater regulatory harmonisation under the MERCOSUL framework. This page summarises the current state of harmonisation and the roadmap.
Current state of harmonisation (2026)
Area Current status Classification framework Harmonised — all MERCOSUL countries use GMC (MERCOSUR Common Market Group) Resolution 40/2000, which establishes a four-class risk classification system (I, II, III, IV)
The regulatory harmonisation roadmap
MERCOSUL's long-term goal is a mutual recognition arrangement where a regulatory approval in one MERCOSUL country is recognised by others — similar to how ASEAN AMDD works for Singapore, Malaysia, Thailand, and other members. Progress has been slow due to differences in regulatory capacity and political priorities.
Key milestones expected:
- Harmonised UDI system across MERCOSUL countries
- Mutual recognition of GMP inspections
- Closer alignment of clinical evidence requirements
Practical implications for manufacturers
Until full harmonisation is achieved, manufacturers must file separate registrations in each MERCOSUL country:
- Brazil → ANVISA
- Argentina → ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica)
- Uruguay → MSP (Ministerio de Salud Pública)
- Paraguay → DINAVISA (Dirección Nacional de Vigilancia Sanitaria)
Documentation prepared to ANVISA/GMC standards is reusable for ANMAT submissions with relatively minor adaptation.
Verify all information against official ANVISA sources before making regulatory decisions.
As of 2026, no firm timeline has been announced for mutual recognition of medical device registrations across MERCOSUL countries. Manufacturers should expect to file separate registrations in each country indefinitely unless MERCOSUL announces a mutual recognition agreement.