The story of the emerging opportunities in China for Medtech. This presentation by Brandwood Biomedical Head of China Operations Dr. Davey Han explores the rapidly changing market in CHina for medical products, the lessons for international manufacturers and the opportunities and success factors in the emerging China market.
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
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
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