The document summarizes the key considerations for TrojanCare to register their insulin infusion pump in Mexico. It outlines the disease profile, healthcare landscape, market opportunities and regulatory requirements. To register, TrojanCare must submit a dossier to Mexico's health authority including device details, labeling and quality certificates. They also require a local representative for registration and distribution. Overall, Mexico provides opportunities through its large diabetes population and trade agreements, but public coverage favors lower-cost alternatives.

1. MEXICO Medical Device Regulations

3. Demographics Estados Unidos Mexicanos - United Mexican States Located in North America between Belize and the US Area: 1,972,550 km 2 Source: CIA - The World Fact book Population: 109,955,400 (7/08 estimate) 31 states + 1 federal district Official language: Spanish Currency: Peso [Conversion: 1 US $ = 12.64 pesos]

6. Leading Causes of Death Source: World Health Statistics Top ten causes of death, all ages (2002) Causes Deaths % All causes 100 Diabetes mellitus 12 Ischemic heart disease 11 Cerebrovascular disease 6 Perinatal condition 6 Cirrhosis of the liver 5 Chronic obstructive pulmonary disease 4 Lower respiratory infections 3 Congenital anomalies 3 Road traffic accidents 3 Hypertensive heart disease 2

7. Diabetes Mellitus Source: World Health Statistics

21. Summary of Requirements b: plus Salud Approval Certificate Requirement Salud IMSS Certificate to foreign government (CFG) X X b Letter of authorization (for distributor) X List of materials X X List of packaging materials X X Manufacturing flow chart X Labels X Directions for use X X Performance specification X X Finished product drawing X X

22. Summary of Requirements Requirement Salud IMSS Sterilization parameters (If applicable) X X Sterility test report (If applicable) X Package integrity tests X Finished product quality control test methods/representative test report X Physical test methods/reports X Stability studies X Clinical publications X Samples X Product brochure X X

23. Summary of the Process RA representative gets the registration request RA representative Request Legalization Required documents are legalized from the Consulate RA collates the submission dossier Local Representative/Distributor submits the dossier to Salud Salud reviews the dossier Submission Cleared

26. Questions