Certifications and Authorizations
ANMAT
www.anmat.gov.ar
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
MINISTRY of NATIONAL HEALTH
www.msal.gov.ar
Resolution 255/94
Authorization for the Establishment of Biomedic Products Sales.
