Be Aware of CFDA Administrative Fee, It Is Going to Come

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 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 21^th 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	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 meets the emergency requirements and pay the emergency fee may decrease the registration duration.
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 19^th 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

Note: medical devices whose registration applications have been accepted by CFDA would be free of administrative fee charge.
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

1. Swift action before the final administrative fee comes out

Because the Notice only announced that the CFAD administrative fee will be charged in the near future, but here is still no definite quotation on how much the corresponding administrative fee would be charged, so only if your application is accepted before the final fee comes out can you avoid paying the administrative fee. Therefore, if you have the recent plan to conduct the CFDA registration, just move it as quickly as possible.

1. Double check your materials before the registration

Since the administrative fee is charged after your application of registration is accepted by CFDA, and there will be no refund if you fail the application. Therefore, you must be very very careful to prepare all steps for your CFDA registration, and make sure all of them are able to satisfy CFDA regulations, which include R&D, risk analysis, technical requirements, manufacturing, product testing, clinical evaluation, etc.

2. Keep the frequent change away

Based on our experience, a lot of establishments would ask for frequent change after receiving the CFDA license, now the change will cost your money, so just try every effort to get rid of unnecessary changes

3. Protect yourself from illegal fees

Except above mentioned administrative fees, please pay attention that all other fees are illegal to be charged.

This news merely indicates that the administrative fee is coming, the state finance ministry & NDRC will enact and issue the detailed fees later.