How to classify the medical device?

The correct classification of your medical product is the premise of enter to the market,Knowing your medical device is classification is very important because:
-Product classification will determine what you need to do before you can sell your product legally.
-The classification will help you establish requirements during the product development phase, specifically design controls.and how to enter your market.
-The classification is an important component in determining how much you will invest to enter your device to market legally and give you rough idea of how long it will take.
Because of this, I’m going to provide you with a little bit of guidance to better understand what to do and how to do it.
The following content is not a comprehensive guide to regulatory submissions, but it should give you some basic guidance and direction on how to classify it.
Here we will list “3 main markets” as below:
1.U.S. Food & Drug Administration, Center for Devices & Radiological Health (FDA CDRH);The US FDA categorizes medical devices into one of three classes – Class I, II, or III – based on their risks and the regulatory controls necessary to provide a reasonable assurance of safety and effectiveness.for example the digital thermometer and infrared thermometer are classified to class II.
2.European Commission,according to official Journal of European union Regulation (EU) MDR 2017/745 Annex VIII,based on the duration of use,invasive/Non-invasive,active or non-active device, the devices are into class I,class IIa,Class IIb and class III. For example the digital upper arm blood pressure monitor and wrist style are Class IIa.
3.China National Medical Products Administration,according to Regulations on the supervision and Administration of medical devices(NO. 739 of the State Council),based on the risk of medical devices,they are classified into 3 levels,class I,class II and class III.also China NMPA has issued the Medical device classification directory and updated from time to time. For example the stethoscope is class I,thermometer and blood pressure monitor are class II.
For the detailed classification procedure and other countries classification path,we should obey the related regulatory and guidance.