CFDA Medical Device Registration Administration Fee Standard (By 12/13/2017) - Regulatory News - Medical Devices

Background:

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

CN: 國家食品藥品監督管理總局關于發布需進行臨床試驗審批的第三類醫療器械目錄的通告（2014年第14號）

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

CN: 國家食品藥品監督管理總局發布關于發布藥品、醫療器械產品注冊收費標準的公告（2015年第53號）

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.

We have launched a LinkedIn newsletter to keep you up to date on the latest developments across the chemical industry including food and FCMs and personal and home care.