Regulatory Authority

Pharmaceutical and Medical Devices Agency (PMDA)


Classification

Class I, II, III, IV


Quality system

The Japanese requirements regarding the Quality Management Systems (QMS) for medical devices are defined by the Ministerial Ordinance #169 (the Japanese PMD Act of the Ministry of Health, Labor and Welfare – MHLW), which is based on ISO 13485. Japan is one of the five MDSAP (Medical Device Single Audit Program) participants, along with Australia, Brazil, Canada and the United States.


Procedure

Medical Devices must be registered with the Regulatory Authority in order to be marketed in Japan.

Class I medical devices require a Premarket Submission.

Class II, III and IV medical devices require registration with PMDA (Premarket certification is needed for specific class II devices, while Premarket Approval is required for some class II and all class III and IV devices).


Applicant

Foreign manufacturers must appoint a Marketing Authorization Holder (MAH, for class I medical devices) or a Designated Marketing Authorization Holder (D-MAH for all the other risk classes).


Timeframe and fees

The registration of medical devices in Japan (Pre-Market Approval and Pre-Market Certification) is complicated, expensive and will generally take from 1 to 3 years depending on the classification of the device. The registration fees are generally established after the first meeting of the MAH/D-MAH with the PMDA.

In case of Pre-Market Submission: once the notification has been sent to the PMDA, the device can be immediately marketed.


Labeling and documentation language

All the documentation and labelling information must be provided in Japanese.


Useful information

The MAH/D-MAH of the foreign manufacturer is required to prepare a periodic report on any accidents, adverse events and recalls from the market, related to the use of the medical device in question.