Who Needs to Comply?

Multiple parties in the supply chain bear regulatory obligations under the PMD Act. Unlike the EU MDR, where the manufacturer bears primary responsibility, Japan's system centres the obligations on the Marketing Authorization Holder (MAH) — who must be Japan-domiciled.

Role	Primary obligation
Marketing Authorization Holder (MAH)	Holds the approval/certification; bears primary post-market obligations
Domestic Manufacturers	Must hold a manufacturing licence; maintain QMS per MO 169
Foreign Manufacturers	Must register with MHLW via FMR; maintain QMS subject to PMDA inspection
Registered Certification Bodies (RCBs)	Conduct Ninsho (Class II) certifications under MHLW oversight
Distributors and Retailers	Distribution licence; record-keeping; reporting obligations