Japanese Regulatory Approval Process for Medical Devices

All manufacturers planning to sell a medical or in vitro diagnostic (IVD) device in Japan must first register their product before placing it on the market. The Ministry of Health, Labour and Welfare (MHLW) oversees registration along with the Pharmaceuticals and Medical Devices Agency (PMDA) and third-party review bodies known as Registered Certification Bodies (RCBs).  

Overview: Medical device registration process in Japan

The chart illustrates the pathway to market per device classification in Japan and is available for download in the Regulatory Affairs Management Suite (RAMS). Only a condensed overview of the main steps for registration is provided here.  

Step 1 
Determine the classification of your device by identifying the appropriate Japanese Medical Device Nomenclature (JMDN) code from the searchable JMDN database.  

Step 2 
Appoint a Marketing Authorization Holder (MAH) or a Designated MAH (DMAH) who will manage the device registration in Japan. Low-risk devices require a MAH, while all other device classes may use a DMAH. 

Step 3 
Foreign manufacturers must submit a Foreign Manufacturer Establishment Registration (FMER) application to the PMDA.

Step 4 
Implement a Quality Management System (QMS) to comply with MHLW Ordinance No. 169.

Step 5 
Prepare the application forms and required documents for the applicable registration route per the device classification.  

Step 6 
Your MAH or DMAH submits the application to the PMDA or an RCB (depending on device class) and pays the fees.  

Step 7 
Depending on device class, the PMDA or the RCB conducts a QMS audit and/or application review and may request additional information. 

Step 8 
Upon approval (except for low-risk devices), the applicable review body will issue a device registration certificate as well as a QMS certificate.