The MHLW is the head agency with the central role in promulgating and administering regulations under the PMD Act.

MHLW releases regulations and publishes guidances, and issues device approvals.

The MHLW conducts operations and services related to pharmaceutical affairs administration while coordinating with the Pharmaceuticals and Medical Devices Agency (PMDA) and prefectural governments.

Similar to the Food and Drug Administration or Health and Human Services government agency

The PMDA is a independent organization under control of the MHLW; does all the day to day work, review applications, handle complaints, vigilance, actively review the application, perform on-site audits if needed.

Submit the application to the MHLW for approval.

Law regulating businesses related to drugs, in vitro diagnostics, quasi-drugs, medical devices, cosmetics and regenerative medicine products in Japan.