New User Fees Set for Foreign Medical Device Manufacturers in China

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)
    Domestic Imported Domestic Imported
Class II Initial Registration – 210,900 – 33,761
Variation Application – 42,000 – 6,723
Renewal (every 5 years) – 40,800 – 6,531
Class III High Risk MD Clinical Trial Approval 43,200 43,200 6,915 6,915
Initial Registration 153,600 308,800 24,588 49,433
Variation Application 50,400 50,400 8,068 8,068
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 

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