Get to Market in Guatemala, Faster and with Full Compliance

Rebexa handles your regulatory registrations with the Ministry of Public Health and Social Assistance (MSPAS) and the Ministerio de Agricultura, Ganadería y Alimentación (MAGA) so your products can launch faster and stay compliant.

Streamlined Regulatory Pathways in Guatemala for Human and Veterinary Products.

Guatemala is a major distribution hub in Central America, but its regulatory process can be bureaucratic and prone to delays. The MSPAS oversees pharmaceuticals and medical devices, while the MAGA regulates veterinary and animal nutrition products.

Rebexa streamlines your entry by coordinating directly with both agencies ensuring your dossiers are complete, your submissions are properly classified, and your approvals stay on track.

What We Handle

  • Dossier formatting and submission to MSPAS and MAGA
  • GMP and legal document legalization
  • Registration certificates for Rx, OTC, and veterinary products
  • Local representative requirements
  • Renewals and post-market variations
  • Labeling translation and approval

We Support

  • Pharmaceuticals (Rx/OTC)
  • Medical devices
  • Veterinary pharmaceuticals
  • Animal feed and supplements
  • Disinfectants and hygiene products

Why Choose Rebexa

  • Local regulatory partnerships
  • Deep understanding of product classification issues
  • Fast issue resolution with health authorities
  • Fully bilingual compliance team

Get Your Product Registered in Guatemala, The Right Way.

Start your market expansion with the right regulatory partner.