The regulatory process for medical devices in Japan involves several key steps: 1) Classifying the device and appointing a Marketing Authorization Holder who will manage the registration process. 2) Implementing a Quality Management System that complies with relevant regulations. 3) Submitting an application to either the Pharmaceuticals and Medical Devices Agency or a Registered Certification Body, depending on the device class. 4) Undergoing an audit and receiving the appropriate certificate before marketing the device in Japan. Device registrations do not expire but must be renewed periodically.

1. The regulatory process for medical devices
You may now begin marketing your device in Japan. Approvals do not expire.**
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.
No certificate issued by PMDA.
Pre-Market Certificate
issued by RCB.
Pre-Market Approval certificate issued by MHLW.
QMS Conformance certificate issued by PMDA or RCB.
Some Class I devices require
QMS conformity assessment
by PMDA.
QMS audit by Registered
Certification Body (RCB).
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.
Submit Pre-Market Submission
to Pharmaceutical and Medical
Devices Agency (PMDA).*
All documents must be
in Japanese.
Submit Pre-Market Certification
application to a Registered
Certified Body (RCB) authorized
to issue certifications. All
documents must be in Japanese.
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.
5000-0115
* MHLW Ordinance #169 documentation is not required in most PMS applications.
** Device registrations do not expire. However, to maintain QMS certification periodic audits will be conducted. 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.
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JPJapan
Determine classification of your device according to the Pharmaceutical and Medical Device Law (PMDL) and Japanese Medical Device Nomenclature (JMDN) codes.
General
Class I
Medical Devices
Specified Controlled
Class II
Medical Devices
Controlled
Class II
Medical Devices
Highly Controlled
Class III
Medical Devices
Highly Controlled
Class IV
Medical Devices
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.
Manufacturers must register their facilities with the PMDA.
Implement Quality Management System (QMS) which complies with the PMDL and Ministry of Health, Labour and Welfare (MHLW) Ordinance #169.
Ordinance #169 is based on ISO 13485.

2. The regulatory process for medical devices
Device classification
in Japan
How long you should
expect to wait after
submission until
approval is granted.
(See note 1)
Validity period for
device registrations.
(See note 2)
Registration
renewal should be
started this far in
advance.
(See note 2)
Complexity of the
registration process for
this classification.
(See note 3)
Overall cost of gaining
regulatory approval.
(See note 4)
CLASS I
General Medical Devices
1 month
Does not
expire
1 month
Simple Complex Low High
CLASS II
Specified Controlled Medical Devices
3-5 months
Does not
expire
1 month
Simple Complex Low High
CLASS II
Controlled Medical Devices
7-9 months
Does not
expire
1 month
Simple Complex Low High
CLASS III
Highly Controlled Medical Devices
9-11 months
Does not
expire
1 month
Simple Complex Low High
CLASS IV
Highly Controlled Medical Devices
13-16 months
Does not
expire
1 month
Simple Complex Low High
JPJapan
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NOTE 1: The time frames shown above are typical for the majority of medical device submissions but assume that your device does not contain animal tissue, medicinal
substances or employ entirely novel technology. Your length of approval will depend on the quality and completeness of your technical documentation and how much time you
take to address additional information requests from authorities after submission. YOUR SUBMISSION(S) MAY TAKE MORE TIME THAN WHAT IS SHOWN ABOVE.
NOTE 2: Device registration does not expire, however you must pay Foreign Manufacturer Registration (FMR) renewal fees. Failure to renew FMR will result in your permission to
market your device being revoked.
NOTE 3: Our rating of the complexity of the registration process is based on our experience and the opinion of nearly 1,000 QA/RA professionals worldwide who were asked
to rate the difficulty of registering a device in each country in January 2014. The European CE Marking process is considered the mid-point to which all other markets are
compared.
NOTE 4: Low = Less than US$5000; Midpoint = US$15000-$30000: High = More than US$50000. Overall cost includes registration application fees, product testing, in-
country representation, submission preparation consulting and translation of registration documents but not IFU. Does not include cost of implementing or auditing a quality
management system compliant with ISO 13485 or US FDA 21 CFR Part 820, if applicable.
© 2014 Emergo Group – You are welcome to publish this chart on your website, or copy it for use in presentations or other materials if it is not cropped in any way. Have
comments or suggestions about the content of this chart? Email us at marketing@emergogroup.com. Chart updated 01/2015.