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 medical user fees for foreign medical device registrants in ChinaCFDA 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

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.

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