This notice clarifies the applicability of newly added general names to specific product categories under the PMD Act classification system.

This notice establishes procedures and requirements for online submission of pharmaceutical and medical device applications to the MHLW and PMDA.

This notice provides guidance on electronic payment methods for application fees and registration license taxes related to pharmaceutical and medical device regulatory submissions.

This notice announces amendments to the ministerial ordinances specifying classifications of high-risk, moderate-risk, general, and specified maintenance management medical devices under the PMD Act.

This notice announces amendments to the ministerial ordinances specifying classifications of high-risk, moderate-risk, general, and specified maintenance management medical devices under the PMD Act.

This notice announces the trial implementation of prioritized review procedures for Software as a Medical Device (SaMD) and related medical device products under the PMD Act to accelerate market access for innovative digital health technologies.

MHLW administrative notice providing Q&A guidance on Software as a Medical Device (SaMD) regulatory handling and requirements under the PMD Act.

MHLW caution alert regarding cybersecurity measures for VPN devices and network equipment connected to medical devices, emphasizing the need for strengthened security protocols to protect medical device networks from cyber threats.

MHLW guidance on procedures for registration applications submitted by organizations seeking to become registered conformity assessment bodies under the PMD Act, including application requirements and administrative handling.

MHLW notice establishing witness inspection procedures for registered conformity assessment bodies and revising on-site inspection implementation standards to ensure compliance and quality oversight.