China Announces New Draft Medical Device Registration Fees

The China Food and Drug Administration (CFDA) recently released a proposed registration fee list for Class II and Class III imported medical device registrations. These fees will likely begin in March of 2015.  For Class I notifications, there are no government fees.

It will cost approximately $33,700 for the registration of an imported Class II medical device. For the registration of an imported Class III device, the government fees will be about $49,400, with a clinical trial approval for a Class III device costing an additional $6,900. Also, the CFDA may offer an expedited device registration pathway for an additional charge, but details on this have not yet been released. Registration renewals for imported Class II or Class III device are required every 5 years and will cost around $6,500.

These fees do not include other costs associated with medical device approval in China such as type testing, clinical trials, in-country representation, and translation costs. Also, remember that some medium-risk devices that are categorized as Class II in the U.S. are considered Class III in China – therefore, you should make sure that your device is correctly classified when registering.