Classification and Category of Medical Devices in China - Regulatory News - Medical Devices

According to the CFDA regulation issued on July 30^th 2014 called ‘Regulations for the Supervision and Administration of Medical Devices (Decree NO. 650)’, medical devices classification is based on the risk level. And the risk level depends on the products’ intended purpose, structural feature, usage, active condition and etc. And medical devices are classified into three categories: Class I, Class II and Class III.

Class I Medical Devices are those with low risk level and the products’ safety and effectiveness can be ensured through routine administration.
Class II Medical Devices are those with moderate risk level that strict administration is required to ensure their safety and effectiveness.
Class III Medical Devices are those with higher risk and must be strictly controlled via special measures in respect to safety and effectiveness.

I) Four Main Methods to Determine the Classification?

a) Search the medical device classification database
The classification of general medical device were confirmed by CFDA according to “The Rules for Classification of Medical Devices”(CFDA Decree No. 15 ) issued on July 14 2015, You can determine the classification by match your product with the product listed in ‘China Medical Device Regulatory Database-CMDRD’

b) Classify Your Product Based Upon the Classification Rule
You can determine the classification for your product according to “The Rules for Classification of Medical Devices” (CFDA order No. 15 2015), the classification should be determined by the comprehensive judgment on three aspects: structural characteristics, form of operation and conditions for use.

c) Apply for Category Determination from CFDA
If you cannot exactly confirm the category of your medical device, applying for the category determination from CFDA is strongly recommended in order to prevent possible confusion caused by improper judgment.

d) If you cannot classify your device through classification catalogue and unwilling to refer to the classification rules or apply for the classification determination from CFDA, you can directly register your device as Class Ⅲ.

*If you would like to determine the classification for your products , please contact us via Lou@cirs-group.com (Ms. Lou)

II) Regulatory Requirements for Each Classes Medical Devices (Initial Imported)

	Local Testing	Local Clinical Trials	Approval
Class I medical devices	Self-testing	Clinical evaluation	Filing
Class II medical devices	Required	Required except the exemption devices	Registration
Class III medical devices	Required	Required except the exemption devices	Registration

*If you would like to get the EN version of ‘The Catalog of Medical Devices Exempted from Clinical Trials’, please contact us via Lou@cirs-group.com.

Reference (CFDA original documents)

Regulations for the Supervision and Administration of Medical Devices (Decree NO. 650)
The Rules for Classification of Medical Devices

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