Japan Regulatory Approval Process for Medical Devices

Download the Chart on the Medical Device Approval Process in JapanSelling a medical device in Japan requires manufacturers to comply with the Japanese Pharmaceutical and Medical Device Act (PMD Act) and its corresponding registration process. This process is overseen by the Pharmaceuticals and Medical Devices Agency (PMDA), a division of the Ministry of Health, Labour and Welfare (MHLW). For more on the registration process, please download the chart below.

The chart shown illustrates the PMDA approval process in Japan and is available for download in PDF format. However, if you would like to explain the steps to someone else in an email, you can cut and paste the text below or send them a link to this page.

The Regulatory Process for Medical devices in Japan

Step 1
Determine classification of your device according to the Japanese Pharmaceutical and Medical Device Act (PMD Act) and Japanese Medical Device Nomenclature (JMDN) codes. Devices are segmented into General Class I – Medical Devices, Specified Controlled Class II – Medical devices, Controlled Class II – Medical devices, Highly Controlled Class III – Medical Devices or Highly Controlled Class IV – Medical Devices.

Step 2
Appoint Marketing Authorization Holder (MAH or D-MAH) to manage your device approval process in Japan. Your MAH or D-MAH will control your device registration.

Step 3
Manufacturers must register their facilities with the PMDA

Step 4
Implement Quality Management System (QMS) which complies with PAL 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 PMDA.* For Specified Controlled Class II devices, submit Pre-Market Certification application to a Registered Certified Body (RCB) authorized to issue certifications. For Controlled Class II, Highly Controlled Class III, and Highly Controlled Class IV devices, prepare Pre-Market Approval application as well as registration dossier in Summary Technical Documnet (STED) format to PMDA. All documents must be in Japanese.

Step 6
Some Class I devices require a QMS conformity assessment by PMDA. Specified Controlled Class II devices will have a QMS audit by an RCB. Controlled Class II, Highly Controlled Class III, and Highly Controlled Class IV devices will undergo a QMS audit by PMDA. On-site audits are typically required for "new" devicees with no existing JMDN code, Class IV devices, and those requireing clinical investigations.

Step 7
All classes will require a QMS conformance certificate issued by PMDA or RCB.

Step 8
Specified Controlled Class II devices will have a Pre-market certificate issued by RCB. Controlled Class II, Highly Controlled Class III, and Highly Controlled Class IV devices will have a Pre-Market Approval certificate issued by MHLW. Class I devices have no certificate issued.

Step 9
All classes, after submission, certification or approval, MAH/D-MAH must submit Import Notification to Regional Bureau of Health and Welfare. In the meantime, 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.**

 

* MHLW Ordinance #169 documentation is not required in most PMS applications.
** To maintain QMS certification periodic audits will be conducted. The schedule will be determined by the RCB or PMDA.

 

© 2014 Emergo Group 
Chart updated: 17/12/2014