Medical device item procedures

Updated: July 2026, 8

In order to distribute a medical device to the market, the following procedures are required depending on the class classification of the medical device itself. 

Medical devices are divided into approval, certification, and notification depending on their class, and the application destination also differs.

If it is a new medical device, an application will be submitted for approval regardless of the class. 

Application procedures for each medical device

What is the Pharmaceuticals and Medical Devices Agency (PMDA)?

The Pharmaceuticals and Medical Devices Agency (PMDA) is a part of the Pharmaceuticals and Medical Devices Agency (PMDA), which is part of the National Institute of Health Sciences Pharmaceuticals and Medical Devices Evaluation Center, the Japan Agency for Relief and Research Promotion of Adverse Drug Reactions, and the Medical Devices Center Foundation. We integrated our operations and became an independent administrative agency that was established on April 16, 4 based on the Pharmaceuticals and Medical Devices Agency Act, and conducts approval review services for pharmaceuticals, medical devices, etc.

In the field of medical devices, we examine Class III and IV manufacturing and sales approval applications, accept Class I manufacturing and sales notifications, and examine foreign manufacturer registration.

What is a third-party certification body?

When manufacturing and selling highly controlled medical devices and controlled medical devices specified by the Minister of Health, Labor and Welfare based on standards, each item must be examined by a third-party certification body registered with the Minister of Health, Labor and Welfare and certified.・Approval must be obtained.

Currently, 10 institutions have received certification and are accepting applications.

▶▶Click here for information on certified medical devices