It was from the end of 2014 that more and more establishments those associated with medical devices began paying great attention to Administrative Fee, which is arising during the CFDA registration, renewal, change and other administrative things.
As CFDA administrative fee attracted dramatic interest, it was on 21th Apr, 2015 that state finance ministry & NDRC released the official notice “Redistribute the CFDA Administrative Fee under Central Management”. (hereinafter referred to as ‘Notice’)
The Notice explicitly stated that the administrative fee raised by drug registration or medical device registration would be re-charged by CFDA. Below table focuses on items will be charged administrative fee during medical device registration:
Items | Remarks |
First registration |
|
Change | |
Renew | |
Clinical trial application of Class III medical devices with very high risk level | |
Emergency fee for first registration, change, renew and clinical trial application |
Even though the Notice was issued, but there is still no definite quotation on how much the corresponding administrative fee would be charged. Based on the internal quotation draft of administrative fee that was formulated by 19th Jan, 2015, please take following table as reference only, the actual fees will not be determined until official files issued.
Items | Domestic (RMB) | Imported (RMB) | |
Class II | first registration | TBA | 210,900 |
change | TBA | 42,000 | |
renew (every five years) | TBA | 40,800 | |
Class III | clinical trial application of medical devices with very high risk level | 43,200 | 43,200 |
first registration | 153,600 | 308,800 | |
change | 50,400 | 50,400 | |
renew (every five years) | 40,800 | 40,800 |
Medical devices which apply for the first registration and meet each of below two requirements can be exempted from administrative fee:
- Medical devices those apply for the special review and approval procedure for innovative medical devices (only for domestic registration);
- The applicants are from small or tiny companies (only for domestic registration).
Our suggestions for you when administrative fee is going to come
- Swift action before the final administrative fee comes out
- Double check your materials before the registration
- Keep the frequent change away
- Protect yourself from illegal fees
This news merely indicates that the administrative fee is coming, the state finance ministry & NDRC will enact and issue the detailed fees later.