China: New CFDA Medical Device Registration Fees in Effect

Chinese regulators have officially increased registration and related fees for Class II and III medical devices, according to the Chinese Food and Drug Administration (CFDA) and Emergo consultants in China.

The official fee increases are in line with draft fees proposed by CFDA in early 2015.

CFDA Medical Device Registration Fees

New Fee

 

 

Domestic

Imported*

Class II

Initial Registration

To be determined by provincial CFDA

$33,992 (USD)

€30,139 (EUR)

Certificate information modification Application

To be determined by provincial CFDA

$6,769 (USD)

€6,001 (EUR)

Extension (Renewal every 5 years)

To be determined by provincial CFDA

$6,576 (USD)

€5,830 (EUR)

Class III

High Risk MD Clinical Trial Approval Application

43,200 RMB

$6,963 (USD)

€6,171 (EUR)

Initial Registration Application

153,600 RMB

$49,775 (USD)

€44,117 (EUR)

Certificate information modification Application

50,400 RMB

$8,124 (USD)

€7,200 (EUR)

Extension (Renewal every 5 years)

40,800 RMB

$6,577 (USD)

€5,829 (EUR)

*Based on currency conversions done 9 June 2015

As previously reported by Emergo, these increases are substantial and may play a bigger role in medical device manufacturers’ decisions on whether to pursue Chinese market authorization. Hopefully any negative impact these increases may have will be offset by CFDA efforts to develop more transparent and predictable device registration pathways.

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