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NMPA Classification of Medical Devices

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Update time : 2021-08-02 20:06:21

Today we take a look at the things you don’t know about the NMPA classification of medical devices.

First, in accordance with Document No. 739 of the Regulations on the Supervision and Administration of Medical Devices issued by the State Drug Administration, medical devices are classified and managed according to the degree of risk.
The first category is low-risk medical devices, and the implementation of routine management can ensure their safety and effectiveness.
The second category is medical devices that have moderate risks and require strict control and management to ensure their safety and effectiveness.
The third category is medical devices that have higher risks and require special measures to strictly control and manage them to ensure their safety and effectiveness.

When you want to determine the classification of a certain product, what methods do we have to determine its classification? Here are several commonly used methods;
Method 1: Search in the "Medical Device Classification Catalog 2017 Edition", "In Vitro Diagnostic Reagent Classification Sub-catalog (2013 Edition)" issued by the Pharmacy Administration and the summary of the classification and definition results of each subsequent batch;
Method 2: Determine your own product classification based on products of the same type that are already on the market;
Method 3: Determine the classification of medical devices according to "Medical Device Classification Rules";

If the classification still cannot be determined through the above methods, it is recommended to apply to the pharmacy for the classification of medical device products.
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