2018_3q_omron_e
27/50 - Strength 1. Regulatory Expertise (Barrier to Entry)
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00:20:57.3
With regard to regulatory approvals, our BPMs are medical devices. As such, they are subject to regulatory approval, under the auspices of the Pharmaceutical Affairs Law in Japan, or the FDA in the US. We must seek approval in each country. We already sell our BPMs in 117 countries, of which 90 require specific approval. In each of the 90 countries where we sought approval, we have built up significant regulatory expertise necessary to do so. This is a significant strategic advantage. For the developing countries, which currently do not have their own approvals process, we would expect to the gradual development of local regulatory approvals processes. Given this, we believe our substantial expertise is a major strength as we strive for further growth. We believe it would be very challenging for new players to try to catch up in this area. Next slide please.
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