As of January 2025, Argentina has officially adopted the new MERCOSUR Technical Regulation for Medical Device Registration (GMC Resolution No. 25/21), replacing the previous Resolution No. 40/00.
Key Highlights:
Harmonized Requirements across MERCOSUR countries (Argentina, Brazil, Paraguay, Uruguay, and Bolivia) to reduce inconsistencies and simplify the registration process.
Acceptance of Foreign Data, allowing the use of regulatory approvals and safety data from recognized international markets.
More Predictable Timelines, with aligned schedules among member countries to facilitate faster market access.
The regulation is being implemented by ANMAT in Argentina and will be progressively adopted by other MERCOSUR nations.
For expert guidance on how this change may impact your medical device approvals, contact TrustCert.
