Japan Regulatory Approval Process for Medical Devices

The Regulatory Process for Medical devices in Japan

Step 1
Determine classification of your device according to the Pharmaceuticals and Medical Devices Act (PMD Act) and Japanese Medical Device Nomenclature (JMDN) codes. There are 5 classes of increasing risk:

1. Class I - General medical devices
2. Class II - Specified Controlled medical devices
3. Class II - Controlled medical devices
4. Class III - Highly Controlled medical devices*
5. Class IV - Highly Controlled medical devices

Step 2
For Class I devices, appoint an MAH in Japan.

For all other classes, Appoint Marketing Authorization Holder (MAH or D-MAH) to manage your device registration in Japan. Your MAH or D-MAH will control your device registration.

Step 3
All classes: Japanese manufacturers must register domestic facilities with local prefectural authorities. Foreign manufacturers must submit a Foreign Manufacturer Registration (FMR) application to the Pharmaceuticals and Medical Devices Agency (PMDA).

Step 4
All classes: Implement Quality Management System (QMS) that complies with the PMD Act and Ministry of Health, Labour and Welfare (MHLW) Ordinance #169. Ordinance #169 is based on ISO 13485.

Step 5
For Class I devices, submit Pre-Market Submission to Pharmaceutical and Medical Devices Agency (PMDA). All documents must be in Japanese.

For Class II (Specified Controlled) devices, submit Pre-Market Certification application to a Registered Certified Body (RCB) authorized to issue certifications. All documents must be in Japanese.

For Class II (Controlled) through IV devices, prepare Pre-Market Approval application as well as registration dossier in Summary Technical Document (STED) format. Submit documents to PMDA. All documents must be in Japanese

Step 6
Class I devices do not require QMS audit.

For Class II (Specified Controlled) devices, QMS audit by Registered Certification Body (RCB).

For Class II (Controlled) through IV devices, QMS audit by PMDA. On-site audits are typically required for “new” devices with no existing JMDN code, Class IV devices, and those requiring clinical investigations.

Step 7
For all Class II through IV devices, your QMS certificate will be issued by the PMDA or your Registered Certification Body.

Step 8
For Class II (Specified Controlled) devices, Pre-Market Certificate issued by RCB.

For Class II (Controlled) through Class IV devices, Pre-Market Approval certificate issued by MHLW.

Step 9
For all devices, a reimbursement application should be filed with Economic Affairs Division of MHLW if applicable.

Step 10
You may now begin marketing your device in Japan. Approvals do not expire.**

*Some Class III medical devices are considered “Specified Highly Controlled” devices and follow the same approval route as Class II "Specified Controlled" devices (shown on the PDF chart in green).

*Device registrations do not expire. However, QMS certificates are valid for five years and must be renewed six months prior to expiration. Pre-Market Certification applications may also be subject to annual surveillance audits. The schedule will be determined by the RCB or PMDA.

This is a simplified overview of the process. The PMDA may choose to audit your submission and request more documents, which will add time to your approval.

Chart updated: 07/15/2019