Medical Device Classification Rules - Medical Device Regulatory Compass - 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 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
Product Category	Second-level subdirectory	260	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.

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