According to State Decree No. 650 Article 77, the registration of medical device can be charged and the fees shall be enacted by finance ministry and national development and reform commission (NDRC).
It was on 21th Apr, 2015 that state finance ministry & NDRC released the official notice “Redistribute the CFDA Administrative Fee under Central Management” and declared the CFDA Administrative Fee will be charged certainly and detailed decree on how much the fee is will be issued soon. Simultaneously, CIRS published the news to predict the detailed fees.
During these days, there are so much more establishments who are associated with medical devices were paying great attention to CFDA administrative fee. Then it was on yesterday that the administrative fee came into force!
The fees in the Notice are almost same with what CIRS had discussed, please refer to following table and be aware of how much fee you will be charged for your product:
Items | Domestic (RMB) | Imported (RMB) | |
Class II | first registration | Local | 210,900 |
change | Local | 42,000 | |
renew (every five years) | Local | 40,800 | |
Class III | first registration | 153,600 | 308,800 |
change | 50,400 | 50,400 | |
renew (every five years) | 40,800 | 40,800 | |
clinical trial application of medical devices with very high risk level | 43,200 | 43,200 |
- Above administrative fees will be charged after your application is accepted by CFDA, and you will receive the bill from CFDA after their acceptance. The fee has to be paid within 5 business days after you receive the bill.
- Above administrative fees are applicable for IVD reagents as well.
- Above change fee is only charged for the permission change, the recording change is free of charge.
- No administrative fee charged for domestic/imported Class I medical device.
- No administrative fee charged for spot check & test.
- Administrative fee of domestic Class II medical device is charged by local provincial food and drug department; administrative fee of domestic Class III device and imported Class II & III device is charged by CFDA.
- Establishment can pay the emergency fee to decrease the registration duration. The emergency fee will be separately enacted and issued soon.
- Administrative fee of medical devices from Hong Kong, Macao and Taiwan are regarded as imported administrative fee.
- The application that is withdrawn by the applicant or unqualified/denied by the CFDA, its administrative fee will not be refunded. The applicant has to pay the administrative fee again in next application.
- Double check your materials before the application
- Accurately definite your registration unit
- Keep permission change away
- Protect yourself from illegal fees