JAPAN
Japan’s regulatory process for medical devices
Determine the classification of your device according to the
Emergo Group assists medical device companies worldwide
with classification, registration, representation, quality system
compliance and distribution in Japan as shown below.
Japan Pharmaceutical Affairs Law (PAL) and JMDN code.
Device classification in Japan
Japan’s classification system differs from the US and Europe so
determining classification of your device(s) can be complex and is
based on Japanese Medical Device Nomenclature (JMDN) codes.
Class I Class II Class II Class III Class IV Through our full service office in Tokyo, we can help determine the
General Medical Specified Controlled Controlled Medical Highly Controlled Highly Controlled correct JMDN code for your device, the first step the ensuring a
Devices Medical Devices Devices Medical devices Medical Devices
smooth registration process.
Japan PMDA medical device and company registration
Japan’s Pharmaceutical and Medical Devices Agency (PMDA)
Appoint Marketing Authorization Holder (MAH* or D-MAH*). Company and device registrations must be requires manufacturers to prepare pre-market applications (Class II,
done through the MAH or D-MAH which controls device registration. III and IV) plus registration dossiers in Summary Technical Document
(STED) format, etc. and pre-market submission (Class 1). Japan does
not accept European CE Marking certificates or national ministry
approvals although European, US or Canadian approval aids the
registration process. Our Tokyo team can prepare your registration
Submit application for “Foreign Manufacturer Accreditation.” documents to ensure a successful review by the Registered
Certification Body or Japanese PMDA. We can also assist with
obtaining Foreign Manufacturer Accreditation on your behalf.
Independent MAH representation in Japan
Implement ISO 13485 Quality Management System (QMS) that also complies with PAL The Marketing Authorization Holder (MAH) plays a critical role
and Ministry of Health, Labour and Welfare (MHLW) Ordinance #169. for the manufacturer in Japan. In fact, the MAH has far more
responsibility for the manufacturer’s device in Japan than any
other regulatory liaison worldwide, including the Authorized
Representative in Europe. Emergo Japan K.K. is a licensed Type
1 Marketing Authorization Holder in Japan. Using Emergo as your
Submit Pre-Market Submit Pre-Market Prepare Pre-Market Approval application
independent D-MAH, instead of appointing a distributor MAH, will
Submission to Certification app. plus registration dossier in STED^ format
ensure that your regulatory responsibilities are handled properly.
PMDA. to RCB.^^ then submit to PMDA.
This also gives you the freedom to appoint new distributors at any
time. More importantly, by selecting an independent D-MAH, your
device approvals will remain under your control.
Compliance with Japan PAL and MHLW Ordinance 169
QMS audit QMS audit^^^ by the PMDA or prefectural
Japan’s Pharmaceutical Affairs Law (PAL) and MHLW Ordinance
by an RCB. regulatory authority.
#169 have specific Quality Management System requirements
that are similar to ISO 13485 and FDA QSR, but with additional
requirements. We can help you modify your existing ISO 13485 or
US FDA compliant QMS to comply with Japan’s requirements and
ensure that you are ready for your PMDA or Registered Certification
Self-declaration, Pre-Market Body audit.
Pre-Market Approval certificate issued by MHLW.
no certificate Certificate Certificates do not expire. Quality system audits
issued by PMDA. issued by RCB.
The Japanese approval process is lengthy and few manufacturers
can afford the delay of failing an audit by the PMDA or Registered
Certification Body. We will make sure you are fully prepared by
conducting a pre-assessment audit and providing the support
necessary to modify your QMS system so it is fully compliant with
MHLW Ordinance #169.
Japanese medical distribution partner evaluation
Japan has a complex social and business culture that is difficult
for westerners to understand. This, combined with obvious
language issues, makes screening distribution partners extremely
challenging. Our Tokyo office can assist you with the process of
finding evaluating and managing distributors in Japan.
* The MAH controls the device approval in Japan. A Designated MAH (D-MAH) acts on behalf of a foreign manufacturer to register medical
devices under the Foreign Special Approval System.
^ STED = Summary Technical Document. This is a harmonized submission format that is accepted for certain regulatory submissions in Japan,
Australia, Europe and Canada.
^^ RCB = Registered Certification Body. Independent companies authorized by the MHLW to certify Specified Controlled Medical Devices and issue
Pre-Market Certifications.
^^^ PMDA may conduct on-site audits for new medical devices, Class IV devices, and devices that require clinical investigations.
© 2011 Emergo Group - May not be reproduced without permission. Chart updated: 01/2011 www.EmergoGroup.com/japan
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