In late May 2015, the China Food and Drug Administration (CFDA) announced an increase in drug and medical device registration fees – effective immediately. The government registration fee for imported pharmaceutical products will increase to $156,500, while imported generic drugs will cost $140,250.
For imported Class II medical devices, the government registration fee will be $34,000 and for imported Class III medical devices it will be $49,800. These are a huge cost because before the government did not charge a fee for medical device registration. Clinical trial applications for high-risk devices will cost almost $7,000. Device re-registration, required every five years, will cost $6,580 for both Class II and Class III devices.
If the CFDA uses the proceeds from the increased registration fees to strengthen its regulatory processes, then product review timelines could decrease. Currently, the registration process for medical devices in China often takes one to three years. On the other hand, it may take 6-8 years to get a drug into the Chinese market.