On September 2, the Japanese MHLW outlined a new accelerated pilot system for SaMD products. Japan already has a priority system called Sakigake, but this system has four main criteria and is not focused on SaMD products. This new pilot system only has 3 main criteria including – 1. The SaMD must be innovative and different from regular medical devices, 2. The SaMD’s usefulness, safety, and efficacy are better than regular medical devices, and 3. The SaMD registration must be done first in Japan or within 30 days of other global filings. For designated innovative SaMD products, preference will be given for consultations, product review, etc.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.