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