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New User Fees Set for Foreign Medical Device Manufacturers in China

Posted 06 February 2015 | By Stewart Eisenhart 

New User Fees Set for Foreign Medical Device Manufacturers in China

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.

CFDA Medical User Fees
 Unit: Chinese Yuan (RMB)Unit: US Dollars (USD)
  DomesticImportedDomesticImported
Class IIInitial Registration-210,900-33,761
Variation Application-42,000-6,723
Renewal every 5 years)-40,800-6,531
Class IIIHigh Risk MD Clinical Trial Approval43,20043,2006,9156,915
Initial Registration153,600308,80024,58849,433
Variation Application50,40050,4008,0688,068
Renewal (every 5 years)40,80040,8006,5316,531
USD figures are calculated based on 1/30/2015 exchange rate of 1 RMB = 0.16008 USD

 

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

Related Post: Further Analysis of New Chinese Medical Device Registration Requirements

Related Post: Further Details on Revised Chinese Authorized Representation, Clinical Evaluation Requirements


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