In order to be placed on the Japanese market, Medical Devices must be registered with the Regulatory Authority according to the device class and the corresponding Japan Medical Device Nomenclature (JMDN) code.
Before submitting the product file, it is necessary for the manufacturer who is not based in Japan to appoint the Marketing Authorization Holder (MAH) and obtain the registration of manufacturing facilities (Foreign Manufacturer Accreditation).
Pre-Market Submission (MAH) notification is required for Class I devices. Some Class I devices require a conformity assessment audit by PMDA. PMDA does not issue certificates for Class I devices. To market these devices, it is enough to present a self-declaration.
For specified controlled Class II devices (medium-low risk), an application must be submitted to a Japanese Registered Certified Body or RCB, designated by PMDA, to obtain Pre-Market Certification. These devices are audited for Quality Management System compliance by the RCB, which then issues a Pre-Market Certificate.
For Class II controlled (medium risk), Class III and Class IV Devices, a Pre-Market Approval application must be submitted to PMDA. PMDA conducts Quality Management System compliance audits, generally for new devices that do not have a JMDN nomenclature code and for Class IV devices that require clinical investigations. A Pre-Market Approval certificate is issued by the MHLW (Ministry of Health, Labor and Welfare) for Class II audited, III and IV devices.
All paperwork for application or submission of documentation to Japanese Regulatory Authorities is carried out by the Marketing Authorisation Holder (MAH) or Designated Marketing Authorisation Holder (D-MAH) with representative duties.
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.
Labelling and documentation language
All the documentation and labelling information must be provided in Japanese.
In some cases it is necessary to carry out safety tests or adjust product and/or system specifications in accordance with Japanese JIS technical standards.