China: New CFDA Medical Device Registration Fees in Effect
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联系我们2015年 5月 28日
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.
作者
- Stewart Eisenhart