NMPA Classification of Medical Devices

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.

Previous : The Production of Mercury-containing Thermometers Will be Baned

Next : Electronic Sphygmomanometer or Mercury Sphygmomanometer?

2025 Hong Kong Baby Products Fair

Jan .13.2025

Each of our carefully prepared exhibits hits the pain points of parenting. Efficient breast pump, with gentle bionic mode, make breastfeeding time easy and pleasant; safe anti-itch instrument, gently press, can quickly for the baby and mother's delicate s

The global event for the medical industry, Medica 2024, opens its doors!

Nov .15.2024

‘From Innovation Ideas to Mass Production’. Here, you will witness how cutting-edge ideas move step by step to mass production and experience the perfect fusion of technology and healthcare.
From the source of innovation in research and development to th

Hong Kong Electronics Fair (Autumn Edition)

Oct .16.2024

Our booth was like a treasure trove of health. There are brand new blood pressure monitors here, accurately controlling the dynamics of blood pressure and protecting your cardiovascular health.
Thermometer, small but powerful, quickly and accurately meas

2024 CMEF Shenzhen

Oct .16.2024

On October 12, our booth made a wonderful debut, with an accurate and reliable sphygmomanometer to protect your health at any time, a sensitive and convenient thermometer to keep an eye on your body temperature changes, and an oximeter that can quickly de