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Certifications and Authorizations

Certifications and Authorizations


Regulation 2319/02

MERCOSUR Technical Regulation about the Operation Authorization of Manufacturing and/or Importer of Medical Products Companies - BO 21/06/02

Regulation 698/99

MERCOSUR Technical Regulation about Good Practice Compliance Verification of Medical Products Manufacturing - BO 16/02/99

Regulation 191/99

MERCOSUR Technical Regulation “Good Practice of Medical Products Manufacturing" - BO 11/02/99

Regulation 5267/06

Management regulation for the processing of request forms of Medical Products on the Producers and Products of Medical Technology Registry, part of the “Mercosur Technical Regulation of Medical Products Registry" - BO 19/09/06

Regulation 2318/02

MERCOSUR Technical Regulation of Medical Products Registry - BO 12/07/02

Regulation 4306/99

MERCOSUR Technical Regulation about Essential Requirements of Safety and Efficiency of Medical Products - BO 20/08/99


Resolution 255/94

Authorization for the Establishment of Biomedic Products Sales.