New User Fees Set for Foreign Medical Device Manufacturers in China
Posted 06 February 2015 | By
Content provided by Emergo, a medical device regulatory affairs and quality assurance consulting firm with offices worldwide.
Chinese medical device market regulator China Food and Drug Administration (CFDA) has published a draft table of user fees for medical device registrants, and is expected to begin enforcing fee requirements in March 2015.
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.
USD figures are calculated based on 1/30/2015 exchange rate of 1 RMB = 0.16008 USD
|CFDA Medical User Fees|
| ||Unit: Chinese Yuan (RMB)||Unit: US Dollars (USD)|
| || ||Domestic||Imported||Domestic||Imported|
|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|
Emergo consultants and partners in China will continue monitoring the Medical User Fee issue and its impact on foreign firms with devices registered for sale in the country.
Original Post: New User Fees Set for Foreign Medical Device Manufacturers in China
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