Amendments to the Pharmaceuticals and Medical Devices Act in Japan

Many medical device and IVD manufacturers active in the Japanese market may already be familiar with the PMD Act and current regulatory framework. However, the PMD Act has undergone several amendments since the regulation first took effect in 2014.

This white paper will discuss key takeaways from the latest round of amendments, which include:

• Expanded fast-track regulatory review processes for some medical and healthcare products
• Mandatory Unique Device Identifier (UDI) labeling requirements and their implications for Japanese market applicants
• Preparing pre-market submissions to the PMDA in light of Japanese regulatory amendments

Understanding the latest changes to the PMD Act can help Japanese medical device market applicants better prepare their premarket submissions to the Pharmaceuticals and Medical Devices Agency (PMDA), minimize errors in their application materials and reduce the risk on noncompliance.