CFDA Administrative Fee is here to pay, rebuild your budget

On 27^th May, 2015 that CFDA issued the Announcement and Notice No. 53 to definite the detailed administrative fee and announced that administrative fee started to be charged from 27^th May, 2015.
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 21^th 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

Please be well noted of below remarks:

1. 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.
2. Above administrative fees are applicable for IVD reagents as well.
3. Above change fee is only charged for the permission change, the recording change is free of charge.
4. No administrative fee charged for domestic/imported Class I medical device.
5. No administrative fee charged for spot check & test.
6. 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.
7. Establishment can pay the emergency fee to decrease the registration duration. The emergency fee will be separately enacted and issued soon.
8. Administrative fee of medical devices from Hong Kong, Macao and Taiwan are regarded as imported administrative fee.
9. 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.

Our suggestions for you in the case of administrative fee

1. Double check your materials before the application

Since the administrative fee is charged after your application 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 materials for your CFDA application, 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. Accurately definite your registration unit

According to CFDA regulations, every individual registration unit has to apply for the unique license. However, sometimes enterprise would be confused of their products, whether their products could apply for one license or have to apply for separate licenses, which will be a critical issue because the administrative fee is charged for every single license.

3. Keep permission change away

Based on our experience, a lot of establishments would ask for frequent change after obtaining the CFDA license. Nevertheless, the permission change (including the change of product name, models, specifications, structure, compositions, applicable scope, technical requirements, manufacturing address, etc.) is going to cost your money, so just try every effort to get rid of unnecessary permission changes and well construct your registration strategy. Additionally, the recording change is still free of charge, which includes the change of applicant name & address, agent name & address, etc.

4. Protect yourself from illegal fees

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