CFDA Medical Device Registration Administration Fee Standard (By 12/13/2017)

Background:

August 25th 2017, CFDA issued the announcement about ‘The Catalog of Clinical Trial Pre-approval Required Class III Medical Devices’

CN: 国家食品药品监督管理总局关于发布需进行临床试验审批的第三类医疗器械目录的通告（2014年第14号）

May 27th 2015, CFDA issued the announcement about ‘Medicine and Medical Device Product Registration Administration Fee Standard’

CN: 国家食品药品监督管理总局发布关于发布药品、医疗器械产品注册收费标准的公告（2015年第53号）

The Catalog of Clinical Trial Pre-approval Required Class III Medical Devices

NO.	Product Name		MD Code
1	Use the new design or the new applicable scope	Implantable cardiac pacemaker, implantable cardiac defibrillator, implantable cardiac resynchronization defibrillator.	6821
2		Implanted blood pump	6845
3		Implantable drug infusion pump	6854
4	The vascular stent systems that have not show in the domestic market.		6846
5	Implant artificial organs, contact artificial organs, orthopedic internal fixation products and orthopedic filling materials that have not show in the domestic market.		6846
6	Absorbable limbs long bone internal fixation.		6846
7	Nanoorthopedic implants		6846
8	Custom additive manufacturing(3D print) orthopaedic implants		6846

Registration Administration Fee Standard

Product	Initial Registration Fee	Alteration Registration Fee	Renewal Registration Fee	Clinical Trial Application Fee
Imported Class I	----	---	---	---
Imported Class II	RMB 210,900	RMB 42,000	RMB 40,800	---
Imported Class III	RMB 308,800	RMB 50,400	RMB 40,800	0 RMB 43,200 (Only for medical devices included in the Catalog of Clinical Trial Pre-approval Required Class III Medical Devices)

* If you have any comments or questions, please contact us at md@cirs-group.com.

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