| Budget & Timetable (MEDICAL DEVICE CLASS II & CLASS III) 1. Cost of medical device registration agency service taken by AdvancedMedicals®: $ 5,500.00. 2. Cost of professional medical literature translation taken by AdvancedMedicals®: $90 per thousand English wards. 3. Cost of drawing technical specification of product taken by the statutory medical device testing institutions of China: 7,000-12,000 RMB/$853 - $1462 (30 working days). 4. Cost of medical device test taken by the statutory medical device testing institutions of China: 7,000-12,000RMB /$853 - $1462(45 working days); 5. Cost of medical device registration taken by SFDA: 3,000 RMB/$366 per Certificate (90 working days). The registration time is 4.5 months since all documents including the technical specification and medical device test report issued by the statutory medical device testing institutions of China are provided; the registration time is 7.5 months since the client designates AdvancedMedicals® to do registration in SFDA; the registration time is shorter than 4.5month in Medical device Class I registration; the certificate is valid for 4 years. The above budget and timetable of registration is just for the general medical device, perhaps the budget or timetable of particular medical device registration is over or below the above. All other cost or fee except for fee of attorney is taken directly by the SFDA and its statutory medical device testing institutions. This is only the evaluation of the attorney and is not the guarantee of the attorney; this is not the precondition of the contract. |