CFDA registration fees will not be insubstantial: Imported Class II device registrants will be charged about $34,000 for initial registration, while foreign Class III device registrants will have to pay about $49,000 for initial registration. Registration renewals every five years for imported devices will cost registrants $6,500 per renewal. User fees will be charged in addition to in-country testing, clinical trials, authorized representation and translation costs.
A translation of the draft fee table below does not include any potential fees for Class I CFDA record filing or CFDA quality system audits.
|CFDA Medical User Fees||Unit: Chinese Yuan (RMB)||Unit: US Dollars (USD)|
|Class II||Initial Registration||–||210,900||–||33,761|
|Renewal (every 5 years)||–||40,800||–||6,531|
|Class III||High Risk MD Clinical Trial Approval||43,200||43,200||6,915||6,915|
|Renewal (every 5 years)||40,800||40,800||6,531||6,531|
USD figures are calculated based on 1/30/2015 exchange rate of 1 RMB = 0.16008 USD
Source: Emergo Group