Japan’s Ministry of Health, Labour, and Welfare (MHWL) has updated its processes and procedures in order to officially accept MDSAP reports starting from 1st April 2022, as evidence of conformity of the quality management system required for Medical Devices registration procedures.

Japan ok MDSAP report starting from 1st April 2022
OK MDSAP report starting from 1st April 2022

Please remember that the Medical Device Single Audit Program (MDSAP) is a program that allows Bodies accredited by the Regulatory Authorities of member countries (US, Canada, Australia, Brazil, and Japan) to conduct a single audit to verify that Medical Devices Manufacturers comply with the quality management system requirements of the relevant countries.

What will change in Japan starting from 1st April?

In the past, to obtain a Medical Device registration certificate, the Japanese Regulatory Authority conducted a document review and an audit in the company.

As from 1st April 2022, with MDSAP reports official acceptance, the process will be simplified since the Regulatory Authority will only conduct the document review.

However, not all Medical Devices can benefit from this simplified process. There is indeed a number of devices that remain excluded, such as products containing animal tissues, radioactive IVD devices, and all sites that reprocess single-use devices.

It should be noted that an additional fee must be paid in order to use the MDSAP report in Japan.

What to do once MDSAP is implemented?

It is advisable to always stay up to date on what changes may be occurring in MDSAP countries. For this reason, we recommend following the regulatory requirements of the MDSAP reference countries through the Regulatory Authorities’ websites, and relevant newsletters to keep up to date from a regulatory perspective. 

Did you know that Thema can support you in implementing and adjusting your quality management system to MDSAP requirements?

Thanks to many years of experience in the field, our consultants can assist you in implementing the quality system for Medical Devices, in accordance with the requirements set out in the regulations of the relevant country.

Contact us for further information and subscribe to our newsletter!


Acceptance of MDSAP reports, MHLW, in force from April 1, 2022