International Classification of Medical Devices

In Japan, medical devices are classified into three classes (general medical devices, managed medical devices, and highly managed medical devices) according to the Pharmaceutical Affairs Law, but are classified into four classes (classes I to IV) according to the international classification. The correlation between the international class classification based on device risk and the classification based on the Pharmaceutical Affaires Law is as follows.
The International Classification, like the Pharmaceuticals and Affaires Low, is classified according to the effects on the human (or animal) body and the degree of risk, depending on the degree of risk, there may be a change in whether or not it is authorized or approved to manufacture, market, or sell the relevant medical device.
The higher the impact and risk to the body, it will be stricter the permit review and approval review naturally.

Classification of medical devices and their relationships

			General medical device	Managed medical device	Highly managed medical device
Risk			Extremely low – low	Low – medium	Medium – extremely high
Permission or approval	Manufacturing and sales	Permission	Require	Require	Require
	Manufacturing and sales	Approval	Not require	Requires approval or third-party certification		Require
	Sales		Not require (except for Specific maintenance medical equipment)	Notification required (Excluding specified maintenance medical equipment)	Need permission (Including special maintenance medical equipment)
Class			Ⅰ	Ⅱ	Ⅲ	Ⅳ
classification by risk			Even if a malfunction occurs, the risk to the human body is considered to be extremely low	Even if a malfunction occurs, the risk to the human body is considered to be relatively low	Items that are considered to have a relatively high risk to the human body when a problem occurs	Highly invasive to the patient, and if a malfunction occurs, may be directly related to the danger of life