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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