Medical Device Classification Rules in China - Regulatory News - Medical Devices

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 requires 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	Filing	Registration	Registration
Production Procedure	Filing	License	Manufacturing License
Distributing Procedure	N/A	Filing	Distributing License

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

- The structure of the new edition of the Catalogue of Medical Devices

			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 from NMPA, the more detail and procedure of classification application can be found here.

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