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Medical Device Classification Rules

I. China's Medical Device Classification Management System

China implements classified management of medical devices according to the degree of risk.

The Class I is the medical device that is low-risk and requires routine management to ensure its safety and effectiveness.

The Class II is the medical device that is moderate-risk and requires strict control and management to ensure their safety and effectiveness.

The Class III is the medical device that is high-risk and require special measures to strictly control management to ensure their safety and effectiveness.

To evaluate the degree of risk of medical devices, factors such as the intended purpose, structural characteristics, and methods of use of medical devices should be considered.

Classification

Class I

Class II

Class III

Registration Procedure

Put on record

Registration

Registration

Production Procedure

Put on record

Production Permit

Production Permit

Business Procedure

N/A

Put on record

Business Permit

II. Regulatory Documents Related to Medical Device Classification

1. Medical Device Classification Rules (CFDA No. 15)

2. Medical Device Classification Catalogue

3. New edition of the Medical Device Classification Catalogue (No. 104 of 2017)

III. Overview of the Latest Edition of the Medical Device Classification Catalogue 

 

Version 2002

New Version

Sub-catalogue

43

22

Product Category

First-level subdirectory

 

260

206

Second-level subdirectory

1157

Referenced Products

1008

6609

 

Settings of Subdirectory

Distribution of Subdirectory

Surgical Medical Device

01. Active surgical device

02. Passive surgical device

03. Neurosurgical and cardiovascular surgical device

04. Orthopedic surgical device

Active Medical Device

05. Radiotherapy device

06. Medical imaging device

07. Medical examination and monitoring device

08. Breathing, anesthesia and first-aid devices

09. Physiotherapy device

10. Blood transfusion, dialysis and extracorporeal circulation device

11. Sterilizing device for medical devices

12. Active implant device

Passive Medical Device

13. Passive implant device

14. Injection, infusion, nursing and protective device

15. Device to carry patients

According to clinical departments

16. Ophthalmic device

17. Stomatological device

18. Gynecological, assisted reproductive, and contraceptive devices

Others

19. Medical rehabilitation device

20. Device for traditional Chinese medicine

21. Medical software

22. clinical examination device

Note: IVD reagents and combination kits are not included in the new catalogue

 

If you are unsure of the classification of your product, you could apply for a medical device classification.