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Ähnlich wie China and You - Medical Devices and IVDDs in the Worlds Second Biggest Economy
Ähnlich wie China and You - Medical Devices and IVDDs in the Worlds Second Biggest Economy (20)
China and You - Medical Devices and IVDDs in the Worlds Second Biggest Economy
- 2. China and You: · Medical Devices & IVDs in the World’s Second Largest Economy Dr. Davey Han
- 4. I want to import or use imported Chinese products. What do I need to know?
- 5. I want to know about the Chinese market:
- 6. How many Medical Devices and IVDs are registered in China?
- 7. What arethe Market Drivers?
- 10. China Facts: Price Comparison
- 13. 2050: 25%A$1 = RMB6.4
- 16. National Healthcare Reform Plan Medical Insurance coverage – above 90% by end 2010
- 18. Increase of government spending on healthcare exceeds overall
- 19. increased rate of government expenditure.Target 22,000 Township Hospitals 300 County Hospitals 400 Chinese Traditional Medical Hospitals 950 Women & Child Hospitals
- 20. National Healthcare Reform Plan Basic Drug and Medical Device System Covers 80% of Grass-Root Medical Institutions Centralised bidding & Procurement Selected Manufacturers Direct Distribution to Hospitals Retail price to patients
- 21. National Healthcare Reform Plan Make health care services equally available for urban and rural residents
- 23. Downwards retail price pressure
- 24. Increased payment rates for professional services
- 25. e.g. fee for surgeon and nurses
- 28. Achieving Reform Plan requires dramatic increase in government spendingon medical products
- 29. Encouraging private investment to build up for-profit hospitals will increase total HC expenditure Conclusion: Opportunitiesfor medical device industry far outweighChallenges
- 31. China: 4.7%
- 33. Market size as % of Global
- 34. 2010: 4%
- 36. 60+ demographic:
- 37. 2020 16%
- 39. Revenue of Medical Devices vs Pharma
- 40. China: 1:5.0
- 41. Global average 1:1.9 Economy growing fast and relatively steadilyHealthcare expenditure grows faster than economy
- 43. Healthcare expansion; state and private
- 46. Is everything cheaper in China than elsewhere?
- 47. Should I manufacture in China?
- 48. What is the regulatory environment?
- 49. Is there risk to my IP?
- 52. Registration
- 53. Labelling
- 54. Classification
- 56. QMS Auditing
- 57. StandardisationThe State Counsel Administrative regulation The Ministries Administrative Provisions China Compulsory Certification
- 58. Different Type of Licenses to Do Business License for Distributor of Selling Medical Device China Compulsory Certification Registration Certificates of Import Medical Devices License of Purchasing Large Med Equipment License of Importation Certificate of Import Inspection Radiation work Permit
- 59. General Process to get SFDA registration Registration Product Standard Type test by SFDA authorized test house Approx. 9 months to finish the process (Can take much longer if not done right) Clinical trial or evaluation Submission to SFDA SFDA Tech review SFDA Admin Approval (Validity for 4 years)
- 60. Imported 4000 3000 2000 1000 0 2005 2006 2007 2008 2009 Year Registrations are complex, but achievable Note: Decrease in 2006/7 caused by major delays during introduction of new registration requirements 2010
- 62. Local China manufacture, with opportunity for lower cost / easier registration pathway?
- 63. what activities of local manufacture are sufficient to label “Made in China”?
- 66. Supplies on time / in full
- 70. Research and consider strategies for importing from China
- 72. effective contacts with government officials
- 73. excellent industry networks including manufacturers and distributors
- 74. ability to integrate all of this into effective strategy
- 75. able to execute on your behalf9/28/2010
- 77. Partnerships established and nurtured
- 79. Sustainable, profitable growthYou need a partner with skills and representation in China and Australia to make this happen.
- 80. Thank You!