As technology continues to revolutionize the healthcare industry, software applications play an increasingly critical role in the medical device industry. In Japan, the regulations surrounding Software as a Medical Device (SaMD) are robust and are specifically designed to ensure patient safety and product efficacy.

The Digital Transformation (DX) Action Strategies for Healthcare (DASH), which is the digital health accreditation program SaMD in Japan, is a voluntary initiative introduced by the Pharmaceuticals and Medical Devices Agency (PMDA) to facilitate the review and approval process for SaMD in the country.

The DASH program aims at promoting the development and adoption of SaMD by providing a streamlined Regulatory pathway. It provides manufacturers with the opportunity to undertake an accelerated review process for their SaMD. Participating in the DASH program can potentially expedite approval timelines, thereby allowing SaMD manufacturers to bring their innovative solutions to the Japanese market more quickly and effectively.

The DASH package includes the following strategies

• Promoting the identification of innovative seeds of SaMD during the early phase to clarify the approval criteria in advance. This involves:
  • Evaluating the technological nuances at the early stages of research.
  • Compiling and releasing a comprehensive review guide that outlines the key attributes of SaMD.
• Centralized consultation services for SaMD regulation.
• A review system applicable to the unique characteristics of SaMD. This includes:
  • Carrying out an efficient review based on the characteristics of SaMD.
  • Utilizing the Post-approval Change Management Protocol (PACMP) scheme.
  • Considering the establishment of the innovative SaMD designation program.
• Strengthening the PMDA organizational structure to aid the review process of SaMD. Some of the developments are:
  • PMDA established a new office that specializes in SaMD.
  • PMDA established the Expert Examination Committee for SaMD.
  • PMDA established collaborative forums to facilitate communication and coordination among regulators, the academia, and the industry.
  • PMDA publishes databases of approval cases.

By participating in the DASH program, SaMD manufacturers can receive support from the PMDA in the form of consultation and guidance throughout the Regulatory process. Thus, the program encourages collaboration between the PMDA and manufacturers, ensuring a smooth and efficient review of SaMD submissions.

To know more about DASH strategies for SaMD in Japan, reach out to our Regulatory experts today. Stay informed! Stay compliant!