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My Presentation on Mexico Medical Device Regulations

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Harshit Thakkar
Harshit Thakkar
1 de 26
MEXICO Medical Device Regulations
Introduction ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
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]
[object Object],[object Object],[object Object],Life Expectancy
Disease Profile ,[object Object],[object Object],[object Object],[object Object]
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
Diabetes Mellitus Source: World Health Statistics
Healthcare Spending ,[object Object],[object Object],[object Object],2004: Popular Insurance (Seguro Popular, SPS) introduced with goal to provide universal health coverage by 2010. In 2008, the timeline was extended to 2030.
Market ,[object Object],[object Object],[object Object],[object Object],[object Object]
TRADE ,[object Object],[object Object],[object Object],[object Object]
Insulin Infusion Pump ,[object Object],[object Object]
Regulatory Environment ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Regulatory Environment ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Regulatory Environment ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],IMSS
Insulin Infusion Pump ,[object Object],[object Object],[object Object]
Regulatory Requirements ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Registration Submission Dossier ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Registration Submission Dossier ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Registration Submission Dossier ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
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
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
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
Advantages ,[object Object],[object Object],[object Object],[object Object],[object Object]
Challenges ,[object Object],[object Object],[object Object],[object Object]
Questions

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My Presentation on Mexico Medical Device Regulations

  • 1. MEXICO Medical Device Regulations
  • 2.
  • 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]
  • 4.
  • 5.
  • 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
  • 8.
  • 9.
  • 10.
  • 11.
  • 12.
  • 13.
  • 14.
  • 15.
  • 16.
  • 17.
  • 18.
  • 19.
  • 20.
  • 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
  • 24.
  • 25.