Chinese Regulators May be Abolishing Medical Device Testing Fees
EMERGO SUMMARY OF KEY POINTS:
- The Chinese government has abolished medical device testing fees at at least four of its testing centers.
- Emergo is awaiting confirmation from additional China Food and Drug Administration (CFDA) testing facilities that they have also stopped assessing these fees.
- Abolishing testing fees should be a boon for foreign medical device companies looking to sell in China.
Update April 11, 2017: Emergo sources in China have now received confirmation from regulators that test centers in Beijing, Tianjin and Jiangsu as well as Shanghai have ceased charging registration testing fees.
The China Food and Drug Administration (CFDA) appears to have stopped charging substantial fees for in-country registration testing of medical devices.
In late March, the Chinese Ministry of Finance announced plans (link in Chinese) to abolish several government fees, including medical device testing fees associated with CFDA registration. That's a big deal because for a typical medium risk device, testing fees can be $5,000 to $10,000. So far, the CFDA’s Shanghai testing center has formally announced (link in Chinese) that it is no longer assessing the fees; Emergo has received additional confirmations from testing centers in Beijing, Tianjin and Jiangsu. The new policy went into effect April 1, 2017.
We will provide further updates as soon as additional testing centers confirm the new policy.
Testing fees for CFDA registrants are substantial; abolishing these fees would remove one barrier to market entry for foreign medical device companies seeking Chinese regulatory approval.