🇦🇷Argentina Medical Device Regulations

Reduced Shelf Life Requirements for Imported Devices

Reduces minimum shelf life required for imported medical devices from one year to six months. Replaces Disposición 1655/1999.

Medical Device Registration Requirements (Current)

Current regulation for medical device registration in Argentina. Replaced Disposición 727/2013 and 5706/17. Establishes labeling and registration requirements.

Good Manufacturing Practices for Medical Devices (Mercosur)

Adopts Mercosur GMC Resolution 20/11 for GMP. Replaced older GMP dispositions (191/99, 698/99). Current GMP requirements for medical devices.

Mercosur Technical Regulation for Medical Device Registration

Core regulation adopting Mercosur GMC Resolution 40/00. Establishes classification (Class I-IV), registration procedures, technical documentation, and labeling requirements.

Manufacturing and Import Authorization Requirements

Governs manufacturing and import authorizations for medical devices. Establishes authorization procedures and associated costs.

Essential Safety and Effectiveness Requirements

Establishes essential requirements for safety and effectiveness of medical devices. Required compliance for Class III and IV devices.