RDC 660 Compliance

Regulatory Framework

ANVISA RDC 660 governs the exceptional importation of unregistered products for compassionate use in Brazil. Our operations are fully aligned with these regulations, ensuring that all products meet the strict requirements for patient-led exceptional importation. We strictly adhere to the guidelines set forth by the Brazilian Health Regulatory Agency (ANVISA), ensuring a transparent and legal pathway for patients to access necessary treatments.

Our Compliance Process

• •Prescription Validation: All imports require valid prescriptions from licensed Brazilian physicians registered with their respective CRM councils. We verify the authenticity of every prescription before processing.
• •Documentation Preparation: Complete ANVISA documentation including patient information, medical justification, and product specifications. We handle the bureaucratic burden to ensure accuracy and speed.
• •Import Authorization: Once ANVISA grants approval, we coordinate the physical importation, customs clearance, and delivery—all under a single tracking system for full transparency.

Patient-Led Import Model

We operate under the patient-led exceptional import framework, where independent medical professionals prescribe treatments, and we coordinate the logistics and regulatory compliance. This model ensures clinical autonomy while maintaining full regulatory compliance. We act solely as a facilitator, ensuring that the patient's right to access health is respected within the bounds of the law.